Is 50,000 IU of vitamin D per week too much. How does vitamin D supplementation affect health. What are the risks and benefits of high-dose vitamin D. When is high-dose vitamin D necessary. How can vitamin D toxicity be prevented.

Understanding Vitamin D Supplementation

Vitamin D is an essential nutrient that plays a crucial role in bone health, immune function, and overall well-being. While the body can produce vitamin D through sun exposure, many people require supplementation to maintain adequate levels. The question of whether 50,000 IU of vitamin D per week is safe has been a topic of discussion among healthcare professionals and researchers.

Recommended Daily Allowance (RDA) for Vitamin D

The Recommended Daily Allowance (RDA) for vitamin D varies depending on age:

• Adults 18-70 years: 600 IU daily
• Adults over 70 years: 800 IU daily

These recommendations are designed to maintain adequate vitamin D levels in healthy individuals. However, in cases of deficiency or certain medical conditions, higher doses may be prescribed.

High-Dose Vitamin D Supplementation

In some cases, healthcare providers may prescribe high doses of vitamin D to correct deficiencies or address specific health concerns. A dose of 50,000 IU per week is considered a high-dose regimen.

When Is High-Dose Vitamin D Necessary?

High-dose vitamin D supplementation may be necessary in the following situations:

1. Severe vitamin D deficiency
2. Malabsorption disorders
3. Certain medications that interfere with vitamin D metabolism
4. Obesity
5. Limited sun exposure

In these cases, a healthcare provider may determine that a high dose is necessary to rapidly correct a deficiency or maintain adequate levels.

Safety of 50,000 IU Vitamin D Per Week

Research suggests that a weekly dose of 50,000 IU of vitamin D can be safe when prescribed and monitored by a healthcare professional. A study conducted on statin-intolerant patients with vitamin D deficiency found that doses ranging from 50,000 to 100,000 IU per week were safe and effective over a 12-month period.

Key Findings from the Study

• Serum vitamin D levels increased significantly without reaching toxic levels
• No significant changes in serum calcium or estimated glomerular filtration rate (eGFR) were observed
• Only a small percentage of patients (1.4% at 6 months, 0.9% at 12 months) had vitamin D levels above 100 ng/mL, but none reached toxic levels (>150 ng/mL)

These findings suggest that high-dose vitamin D supplementation can be safe when properly monitored.

Potential Risks of High-Dose Vitamin D

While high-dose vitamin D supplementation can be safe under medical supervision, it is not without potential risks. Vitamin D toxicity, also known as hypervitaminosis D, is rare but can occur with excessive supplementation.

Symptoms of Vitamin D Toxicity

Potential symptoms of vitamin D toxicity include:

• Allergic skin reactions
• Calcium buildup in the arteries
• Headaches
• Muscle pain
• Kidney or urinary stones
• Gastrointestinal issues (nausea, vomiting, constipation, diarrhea)

It is crucial to report any adverse reactions to your healthcare provider immediately.

Monitoring Vitamin D Levels

Regular monitoring of vitamin D levels is essential when taking high-dose supplements. Healthcare providers typically use blood tests to measure serum 25-hydroxyvitamin D levels, which reflect overall vitamin D status.

Optimal Vitamin D Levels

The optimal range for serum vitamin D levels is generally considered to be:

• Sufficient: 30-50 ng/mL (75-125 nmol/L)
• Insufficient: 21-29 ng/mL (52-72 nmol/L)
• Deficient: <20 ng/mL (<50 nmol/L)

Your healthcare provider will interpret your results and adjust your supplementation regimen accordingly.

Factors Affecting Vitamin D Absorption and Metabolism

Several factors can influence how your body absorbs and metabolizes vitamin D, potentially affecting the safety and efficacy of high-dose supplementation:

• Age
• Body weight
• Skin pigmentation
• Geographical location and sun exposure
• Diet
• Certain medical conditions (e.g., liver or kidney disease)
• Medications

These factors underscore the importance of personalized vitamin D supplementation under medical supervision.

Alternative Approaches to Vitamin D Supplementation

While high-dose vitamin D supplementation may be necessary in some cases, there are alternative approaches to maintaining adequate vitamin D levels:

Dietary Sources of Vitamin D

Incorporating vitamin D-rich foods into your diet can help boost your levels naturally:

• Fatty fish (salmon, mackerel, tuna)
• Egg yolks
• Fortified dairy products
• Fortified cereals and juices
• Mushrooms exposed to UV light

Safe Sun Exposure

Controlled sun exposure can help your body produce vitamin D naturally. However, it’s important to balance sun exposure with skin cancer prevention. Consult your healthcare provider for personalized recommendations.

Vitamin D and Overall Health

Maintaining adequate vitamin D levels is crucial for overall health. Vitamin D plays a role in various bodily functions beyond bone health:

• Immune system regulation
• Muscle function
• Cardiovascular health
• Mood regulation
• Cancer prevention (under investigation)

Given its wide-ranging effects, ensuring optimal vitamin D levels through appropriate supplementation or lifestyle measures is important for overall well-being.

Conclusion: Balancing Benefits and Risks

While a weekly dose of 50,000 IU of vitamin D can be safe and effective when prescribed and monitored by a healthcare professional, it is not appropriate for everyone. The key to safe vitamin D supplementation lies in personalized care, regular monitoring, and open communication with your healthcare provider.

If you have been prescribed high-dose vitamin D or are considering supplementation, discuss the following with your healthcare provider:

• Your current vitamin D levels
• Potential risks and benefits of high-dose supplementation
• Alternative approaches to improving vitamin D status
• Monitoring schedule and follow-up plan

By working closely with your healthcare team, you can ensure that your vitamin D supplementation regimen is safe, effective, and tailored to your individual needs.

Is 50,000 IU of Vitamin D Per Week Too Much?

Asked by Jerri Koch

Question:

Are 50,000 International Units (IU) Of vitamin D Once A Week Harmful?

My doctor prescribed 50,000 IU of vitamin D, to be taken once a week due to vitamin D deficiency. Is this safe to take? Is there any way it would be toxic?

Answer:

The dose that your physician prescribed is likely safe if used on a short-term basis. The Recommended Daily Allowance (RDA) for vitamin D is 600 IU for adults 18-70 years of age, and 800 IU for adults over 70. Vitamin D supplementation appears to be safe for adults when taken by mouth in doses of 4,000 IU daily (for a total of 28,000 IU per week).

When vitamin D deficiency is present, experts recommend a range of 40-2,000 IU of vitamin D each day depending on the severity of the deficiency. While the upper limit of this recommendation is 2,000 IU per day, research shows that high doses of vitamin D (10,000 to 50,000 IU daily) may be necessary for patients who have a history of malabsorption.

While vitamin D toxicity (also called hypervitaminosis D) is rare, it can have serious side effects. These include allergic skin reactions, a build-up of calcium in the arteries, headaches, muscle pain, kidney or urinary stones, and gastrointestinal problems (such as nausea, vomiting, constipation, and diarrhea).

Your vitamin D levels should be monitored closely during this time of high-dose supplementation. Report any adverse reactions to your doctor immediately.

You should know: The answer above provides general health information that is not intended to replace medical advice or treatment recommendations from a qualified healthcare professional.

You should know: The answer above provides general health information that is not intended to replace medical advice or treatment recommendations from a qualified healthcare professional.

Meet Our Writer

Carmen Roberts, M.S., R.D., L.D.N.

Carmen is a Registered Dietitian. In addition to writing for HealthCentral, she has spent her career working at Johns Hopkins and is also an adjunct faculty instructor for Excelsior College. Carmen has over 20 years of experience in nutritional counseling, education, writing, and program management and is a certified specialist in adult weight management. She enjoys educating her students and clients about how nutrition affects the body and its role in overall health and wellness.

Safety of 50,000-100,000 Units of Vitamin D3/Week in Vitamin D-Deficient, Hypercholesterolemic Patients with Reversible Statin Intolerance

Abstract

Background:

Vitamin D deficiency (<32 ng/mL) is a reversible cause of statin-intolerance, usually requiring vitamin D3 (50,000-100,000 IU/week) to normalize serum D, allowing reinstitution of statins. Longitudinal safety assessment of serum vitamin D, calcium, and estimated glomerular filtration rate (eGFR) is important.

Aims:

Prospectively assess the safety-efficacy of vitamin D3 therapy.

Materials and Methods:

In 282 statin-intolerant hypercholesterolemic patients for 6 months and in 112 of the 282 patients for 12 months, with low-entry serum vitamin D (<32 ng/mL), we assessed safety-efficacy of vitamin D3 therapy (50,000-100,000 IU/week).

Results:

On mean (66,600 IU) and median (50,000 IU) of vitamin D3/week in 282 patients at 6 months, serum vitamin D rose from pretreatment (21—median) to 46 ng/mL (P < 0.0001), and became high (>100 ng/mL) but not toxic (>150 ng/mL) in 4 patients (1.4%). Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 at 6 months (P = .36), with no trend of change (P = .16). Median eGFR was unchanged from entry (84 mL/min/1.73) to 83 at 6 months (P = .57), with no trend of change (P = .59). On vitamin D3 71,700 (mean) and 50,000 IU/week (median) at 12 months in 112 patients, serum vitamin D rose from pretreatment (21—median) to 51 ng/mL (P < 0.0001), and became high (>100 but <150 ng/mL) in 1 (0.9%) at 12 months. Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 mg/dL and 9.60 mg/dL at 6 months and 12 months, respectively; P > 0.3. eGFR did not change from 79 mL/min/1.73 at entry to 74 mL/min/1. 73 and 77 mL/min/1.73 at 6 months and 12 months, P > 0.3. There was no trend in the change in serum calcium (P > 0.5 for 6 months and 12 months), and no change of eGFR for 6 months and 12 months, P > 0.15.

Conclusions:

Vitamin D3 therapy (50,000-100,000 IU/week) was safe and effective when given for 12 months to reverse statin intolerance in patients with vitamin D deficiency. Serum vitamin D rarely exceeded 100 ng/mL, never reached toxic levels, and there were no significant change in serum calcium or eGFR.

Keywords: Deficiency, estimated glomerular filtration rate (eGFR), hypercalcemia, myalgia, myositis, hypervitaminosis D, serum calcium, supplementation, Vitamin D

Introduction

To understand the safety parameters of therapeutic vitamin D supplementation, it is important to know that 10,000-25,000 IU/day are made in the skin in response to adequate sunlight exposure.[1,2,3,4,5]

From 1934 to 1946, supraphysiological doses of vitamin D (25(OH)D) were used in the treatment of rheumatoid arthritis (200,000-600,000 IU/day),[6] 60,000-300,000 IU/day for asthma[7] and 100,000-150,000 IU/day for tuberculosis. [8] However, after months of supplementation at these doses, hypercalcemia often appeared,[6,7] with reports of resultant deaths.[9,10] Subsequently, much smaller doses of vitamin D were used to treat rickets, limited to 200 units per day.[11]

According to the Institute of Medicine, a serum 25(OH)D level of 25 ng/mL is adequate for most of the population[12] while levels >50 are high. However, much more widely used clinical normal ranges are 30-100 ng/mL[13] or 32-100 ng/mL.[4] Serum 25(OH)D of 100 ng/mL is considered by several groups to be the laboratory upper normal limit.[4,13] In treating chronic plaque psoriasis, serum vitamin D levels >50 and ranging up to 112 ng/mL were not a cause for concern.[14]

Many studies have been conducted to assess the adverse outcomes of vitamin D supplementation at various dose levels.[3,15,16,17,18,19] In normal healthy subjects, no adverse outcome was reported by Heaney et al.,[15] giving 836 IU/day, 5500 IU/day or 11,000 IU/day. Serum vitamin D levels rose from 28.1 to 64 ng/mL in 5 months in the 5,500 IU/day group, and rose to 88 ng/mL in the 11,000 IU/day group.[15] Ten thousand units/day has been proposed as a safe tolerable upper intake level, and it has been estimated that serum 25(OH)D levels >240 ng/mL would be required to result in clinically significant hypercalcemia.[16] In 2011, a community-based study with 3,667 subjects reported that dosing with 10,000 IU/day was safe, with no reported serum 25(OH)D level >200 ng/mL.[17] With 4,000 IU/day of D3 given for 1 year in two studies, no adverse effect due to vitamin D supplementation was reported,[18,19] and mean serum 25(OH)D levels after 12 months were 66ng/mL and 67 ng/mL.

In a 10-year population study, the incidence of serum 25(OH)D values >50 ng/mL increased significantly without a corresponding increase in serum calcium values or with the risk of hypercalcemia.[20] As recently summarized by Hossein-Nezhad and Holick, “serum 25(OH)D levels are usually markedly elevated (>150 ng/ml) in individuals with vitamin D intoxication,”[21] and daily doses of vitamin D3 up to 10,000 IU were safe in healthy males. [15,16]

One potential adverse outcome of high dose oral vitamin D supplementation might be the development of nephrocalcinosis but kidney stone development has not been reported for patients taking oral vitamin D3 up to 11,000 IU per day.[2,15,16,17,18,19] Moreover, there are no links reported[22,23,24,25] between oral vitamin D intake and development of kidney stones.

Statin-induced myalgia is a major cause of statin intolerance[26,27,28,29,30] and is common, reported in 27% of the subjects treated with statins.[29] Statin therapy in community-dwelling older adults may exacerbate muscle performance decline and falls associated with aging without a concomitant decrease in muscle mass, a reversible effect after the cessation of statins.[31]

Most[24,26,27,28,32,33,34,35,36,37] but not all[38,39,40] recent studies have suggested that low serum vitamin D additively or synergistically interacts with statins to produce myalgia-myopathy.

Since myalgia, myositis, myopathy, and/or myonecrosis are the major causes of statin intolerance,[41] and the association of serum vitamin D deficiency, statin treatment, and myalgia, myositis, myopathy and/or myonecrosis has physiologic plausibility,[42,43,44,45,46,47] resolution of vitamin D deficiency interacting with statins to produce myalgia, myositis, myopathy, and/or myonecrosis would have significant clinical importance, allowing reinstitution of statins to optimize reduction of Low-density lipoprotein cholesterol (LDLC) and prevent cardiovascular disease. [48]

In the current study, our specific aim was determine whether and to what degree vitamin D3 supplementation of 50,000-100,000 IU/week for 6-12 months in 282 vitamin D-deficient, statin-intolerant patients was safe with regard to the development of serum hypervitaminosis D, hypercalcemia, or changes in the calculated estimated glomerular filtration rate (eGFR).

Materials and Methods

Institutional review board-approved protocol

The study followed an institutional review board-approved protocol with signed informed consent.

Statin-intolerant patients with low serum vitamin D (<32 ng/mL)

In the temporal order of their referral from Midwestern physicians (Ohio, Kentucky, Indiana, West Virginia), we prospectively studied hypercholesterolemic patients with statin intolerance (unable to tolerate ≥2 statins) who were found by us to have serum 25(OH)D <32 ng/mL, our laboratory lower normal limit. After experiencing myalgia, myositis, myopathy, and/or myonecrosis, most referred patients refused to take another statin unless steps were taken to explicate and treat[26,27,28,48] the pathoetiology of their statin intolerance.

We excluded patients who had previously developed rhabdomyolysis during statin therapy and those who were taking corticosteroids at study entry or who had comorbidities that would result in muscle or bone pain (diabetic sensory neuropathy, fibromyalgia, polymyalgia rheumatica, arthritis, peripheral vascular disease, sensory neuropathy, and hypothyroidism). Age was not used as an inclusion or exclusion criterion. After the above inclusions and exclusions, we prospectively studied 282 patients treated with 50,000-100,000 IU vitamin D3/week for 6 months, and 112 of these 282 patients for 12 months.

Laboratory determinations

At the initial visit, after an overnight fast, blood was drawn and measured for serum total 25(OH)D by LabCorp using two-dimensional liquid chromatography (HPLC) with tandem mass spectrometry detection after protein precipitation.[49] The laboratory lower normal limit for total 25(OH)D was 32 ng/mL.[49] Additional measures included plasma cholesterol, triglyceride, HDL cholesterol (HDLC), and LDLC, serum calcium, and phosphorous, along with creatine phosphokinase (CK), glucose, insulin, and renal (electronic GFR), thyroid, and liver function tests. At each follow-up visit, fasting blood was obtained for serum total 25(OH)D levels, serum calcium and phosphorous, eGFR, lipid profile, CK, glucose, and liver function tests.

Vitamin D supplementation and prospective follow-up

After documentation of low serum 25(OH)D at study entry, the 282 statin-intolerant, vitamin D-deficient patients were started on vitamin D3 by prescription[50] with 161 (57%) given ≤50,000 IU/week (median: 50,000 units/week) and 113 (40%) >50,000 IU/week but ≤100,000 IU/week (median 100,000 units/week). Only 8 patients (2.8%) were given >100,000 IU/week, with the highest dose 150,000 IU/week in 3 patients.

Patients were prospectively reassessed at 6-month intervals for 1 year [ and Figures –], with remeasurement of serum vitamin D, serum calcium, and eGFR. At each follow-up visit, a detailed history was obtained for statin and prescription drug use, and the amount of vitamin D supplementation.[48]

Table 1

Serum vitamin D, calcium, and eGFR at pretreatment entry and up to 6-month and 12-month therapies with 50,000-100,000 IU/week of vitamin D3

Serum calcium and eGFR at pretreatment entry and at the 6-month follow-up on vitamin D3 supplementation in 282 patients, median, 25^th-75^th percentiles are exhibited

Serum calcium and eGFR at pretreatment entry and at the 6-month, 12-month follow-ups on vitamin D3 supplementation in 112 patients, median, and 25^th-75^th percentiles are exhibited

Statistical methods

Based on our recent study of 146 vitamin D-deficient, statin-intolerant patients with pretreatment serum vitamin D 21 ± 7 ng/mL and levels 57 ± 19 ng/mL on supplementation,[48] power and sample size were calculated. We would have needed 24 patients before and on vitamin D supplementation to be able to observe the vitamin D treatment effect, with serum vitamin D increasing at least 20 ng/mL at a significance level of P = 0.05, with power of 80%.

Differences between pretreatment serum vitamin D, calcium, and eGFR and levels at 6 months and 12 months on vitamin D supplementation were assessed by paired Wilcoxon tests of difference. McNemar’s tests were used to check trends over time in serum calcium and eGFR (normal→abnormal or abnormal→normal).

Results

Follow-up for 6 months

As summarized in , at study entry there were 282 patients (155 men, 127 women) who had measurements of serum 25(OH)D at pretreatment entry and at 6-month follow-up. By selection, pretreatment serum vitamin D was low (<32 ng/mL) in all patients, with median levels of 21.3 ng/mL []. On 6-month follow-up on vitamin D supplementation (median 50,000 IU D3/week), median serum vitamin D rose to 46. 1 ng/mL (P <.0001). Of the 282 patients, serum vitamin D levels rose into the normal range (>32 ng/mL) in 222 (79%), with 56 (20%) still low (<32 ng/mL) (median: 25 ng/mL). Serum vitamin D levels rarely rose above the laboratory upper normal limit (100 ng/mL) (n = 4, 1.4% of 282 patients, 101 ng/mL, 106 ng/mL, 140 ng/mL, 140 ng/mL) at 6-month follow-up [].

On vitamin D supplementation, no patient had serum vitamin D levels in the hypervitaminosis range (>150 ng/mL) []. On vitamin D supplementation, serum calcium was unchanged (P = .36), as was eGFR (P = .57). There was no significant trend of change in serum calcium (McNemar P = .16) or in eGFR (P = .59) from entry to 6-month follow-up [ and ].

Of the 282 patients with pretreatment serum vitamin D <32 ng/mL, 183 were unable to tolerate any statin pre-vitamin D treatment because of myalgia-myositis. At 6-month follow-up on vitamin D supplementation, 136 of these 183 patients (74%) were able to tolerate statin therapy without myalgia-myositis. Of the 99 patients taking statins at the study entry, at 6-month follow-up on vitamin D supplementation 84 (85%) continued statins without symptoms.

Sequential follow-up for 12 months

Of the 282 patients, 112 (65 men, 47 women) had both 6-month and 12-month follow-ups on vitamin D3 supplementation (median 50,000 IU/week). Median serum vitamin D rose to the normal range and remained in it []. On vitamin D supplementation, 87 of the 112 patients (78%) had serum vitamin D in the normal range (32-100 ng/mL) and 21 (19%) had serum vitamin D still low at 6 months (median 26 ng/mL). At 12 months, 87/112 (78%) patients had vitamin D in the normal range, and 24 (21%) had serum vitamin D below 32 (median 26 ng/mL). Serum vitamin D levels rarely rose above the laboratory upper normal limit (100 ng/mL) [n = 4 ng/mL, 101 ng/mL, 106 ng/mL, 140 ng/mL, 140 ng/mL, (3.6%) at 6 months, n = 1, 126 ng/mL (0.9%) at 12 months], and no patient had serum vitamin D levels in the hypervitaminosis range (>150 ng/mL) [].

At follow-up, on vitamin D3 supplementation, serum calcium was unchanged (P = .37 for month 6, P = .38 for month 12) as was GFR (P = .49 for month 6, P = .38 for month 12). There was no significant trend of change in serum calcium (P > .5) or in eGFR (P > .1) by McNemar’s test [ and ].

Of the 112 patients with pretreatment serum vitamin D <32 ng/mL, and 12-month follow-up, 82 were unable to tolerate any statin pre-vitamin D treatment because of myalgia-myositis. At 12-month follow-up on vitamin D supplementation, 74 (90%) of these 82 patients were able to tolerate statin therapy without myalgia-myositis. Of the 30 patients taking statins at study entry, at 12-month follow-up on vitamin D supplementation, 29 (97%) continued statins without symptoms.

Discussion

Low serum vitamin D is associated with statin intolerance in most studies,[26,27,28,31,32,33,34,35,36] and vitamin D3 supplementation appears to reverse statin intolerance in most studies[33,34,35,37] including our four previous reports. [26,27,28,48]

In our most recent study of 146 vitamin D-deficient, statin-intolerant patients,[48] the amount of vitamin D3 supplementation used was 50,000-100,000 units/week, and there was no adverse effect at this level of supplementation. In the current study, in a larger cohort of statin-intolerant patients with low pretreatment serum vitamin D (<32 ng/mL), with vitamin D3 supplementation of 50,000-100,000 units/week, there was no significant change in calcium levels and no significant change in eGFR. Moreover, none of the patients developed serum vitamin D levels >150 ng/mL, conventionally identified as hypervitaminosis D,[21] and very few (<4%) had serum vitamin D levels above the laboratory upper normal limit of 100 ng/mL. In the current study, vitamin D3 supplementation (50,000-100,000 units/week) for amelioration of vitamin D-dependent statin intolerance[26,27,28,48] was safe, as determined by the lack of change in serum calcium, eGFR, or development of hypervitaminosis D.

In the current study, at 6-month and 12-month follow-ups on vitamin D supplementation, 74% and 90%, respectively, of statin-intolerant patients, none of whom would take any statin at the pretreatment baseline, were able to successfully take statins.

Our finding of the safety of vitamin D3 supplementation of 50,000-100,000 units per week is paralleled by previous studies providing 11,000 units per day.[15,16] As recently summarized by Hossein-Nezhad and Holick, “…daily doses of vitamin D3 up to 10,000 IU were safe in healthy males.”[21]

Our paper is limited as it is not double-blind and placebo-controlled but this design is difficult to carry out in statin-intolerant patients who refuse, as did the patients in the current study, to try any new statin therapy without an antecedent attempt to reverse low serum vitamin D at study entry.

Overall, in our initial four reports[26,27,28,48] we have provided supplemental vitamin D3 to 402 statin-intolerant patients with low serum vitamin D at entry, of whom 352 (88%) were subsequently able to tolerate a rechallenge of statins with excellent tolerability and LDLC lowering to targeted levels. [51] The documentation of safety of 50,000-100,000 IU/week of vitamin D3 supplementation for up to 1-year follow-up as documented in the current study is important, given the utility of vitamin D supplementation as an approach to reverse statin intolerance.[48]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Safety of 50,000-100,000 Units of Vitamin D3/Week in Vitamin D-Deficient, Hypercholesterolemic Patients with Reversible Statin Intolerance

Abstract

Background:

Vitamin D deficiency (<32 ng/mL) is a reversible cause of statin-intolerance, usually requiring vitamin D3 (50,000-100,000 IU/week) to normalize serum D, allowing reinstitution of statins. Longitudinal safety assessment of serum vitamin D, calcium, and estimated glomerular filtration rate (eGFR) is important.

Aims:

Prospectively assess the safety-efficacy of vitamin D3 therapy.

Materials and Methods:

In 282 statin-intolerant hypercholesterolemic patients for 6 months and in 112 of the 282 patients for 12 months, with low-entry serum vitamin D (<32 ng/mL), we assessed safety-efficacy of vitamin D3 therapy (50,000-100,000 IU/week).

Results:

On mean (66,600 IU) and median (50,000 IU) of vitamin D3/week in 282 patients at 6 months, serum vitamin D rose from pretreatment (21—median) to 46 ng/mL (P < 0.0001), and became high (>100 ng/mL) but not toxic (>150 ng/mL) in 4 patients (1.4%). Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 at 6 months (P = .36), with no trend of change (P = .16). Median eGFR was unchanged from entry (84 mL/min/1.73) to 83 at 6 months (P = .57), with no trend of change (P = .59). On vitamin D3 71,700 (mean) and 50,000 IU/week (median) at 12 months in 112 patients, serum vitamin D rose from pretreatment (21—median) to 51 ng/mL (P < 0.0001), and became high (>100 but <150 ng/mL) in 1 (0.9%) at 12 months. Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 mg/dL and 9.60 mg/dL at 6 months and 12 months, respectively; P > 0.3. eGFR did not change from 79 mL/min/1.73 at entry to 74 mL/min/1. 73 and 77 mL/min/1.73 at 6 months and 12 months, P > 0.3. There was no trend in the change in serum calcium (P > 0.5 for 6 months and 12 months), and no change of eGFR for 6 months and 12 months, P > 0.15.

Conclusions:

Vitamin D3 therapy (50,000-100,000 IU/week) was safe and effective when given for 12 months to reverse statin intolerance in patients with vitamin D deficiency. Serum vitamin D rarely exceeded 100 ng/mL, never reached toxic levels, and there were no significant change in serum calcium or eGFR.

Keywords: Deficiency, estimated glomerular filtration rate (eGFR), hypercalcemia, myalgia, myositis, hypervitaminosis D, serum calcium, supplementation, Vitamin D

Introduction

To understand the safety parameters of therapeutic vitamin D supplementation, it is important to know that 10,000-25,000 IU/day are made in the skin in response to adequate sunlight exposure.[1,2,3,4,5]

From 1934 to 1946, supraphysiological doses of vitamin D (25(OH)D) were used in the treatment of rheumatoid arthritis (200,000-600,000 IU/day),[6] 60,000-300,000 IU/day for asthma[7] and 100,000-150,000 IU/day for tuberculosis. [8] However, after months of supplementation at these doses, hypercalcemia often appeared,[6,7] with reports of resultant deaths.[9,10] Subsequently, much smaller doses of vitamin D were used to treat rickets, limited to 200 units per day.[11]

According to the Institute of Medicine, a serum 25(OH)D level of 25 ng/mL is adequate for most of the population[12] while levels >50 are high. However, much more widely used clinical normal ranges are 30-100 ng/mL[13] or 32-100 ng/mL.[4] Serum 25(OH)D of 100 ng/mL is considered by several groups to be the laboratory upper normal limit.[4,13] In treating chronic plaque psoriasis, serum vitamin D levels >50 and ranging up to 112 ng/mL were not a cause for concern.[14]

Many studies have been conducted to assess the adverse outcomes of vitamin D supplementation at various dose levels.[3,15,16,17,18,19] In normal healthy subjects, no adverse outcome was reported by Heaney et al.,[15] giving 836 IU/day, 5500 IU/day or 11,000 IU/day. Serum vitamin D levels rose from 28.1 to 64 ng/mL in 5 months in the 5,500 IU/day group, and rose to 88 ng/mL in the 11,000 IU/day group.[15] Ten thousand units/day has been proposed as a safe tolerable upper intake level, and it has been estimated that serum 25(OH)D levels >240 ng/mL would be required to result in clinically significant hypercalcemia.[16] In 2011, a community-based study with 3,667 subjects reported that dosing with 10,000 IU/day was safe, with no reported serum 25(OH)D level >200 ng/mL.[17] With 4,000 IU/day of D3 given for 1 year in two studies, no adverse effect due to vitamin D supplementation was reported,[18,19] and mean serum 25(OH)D levels after 12 months were 66ng/mL and 67 ng/mL.

In a 10-year population study, the incidence of serum 25(OH)D values >50 ng/mL increased significantly without a corresponding increase in serum calcium values or with the risk of hypercalcemia.[20] As recently summarized by Hossein-Nezhad and Holick, “serum 25(OH)D levels are usually markedly elevated (>150 ng/ml) in individuals with vitamin D intoxication,”[21] and daily doses of vitamin D3 up to 10,000 IU were safe in healthy males. [15,16]

One potential adverse outcome of high dose oral vitamin D supplementation might be the development of nephrocalcinosis but kidney stone development has not been reported for patients taking oral vitamin D3 up to 11,000 IU per day.[2,15,16,17,18,19] Moreover, there are no links reported[22,23,24,25] between oral vitamin D intake and development of kidney stones.

Statin-induced myalgia is a major cause of statin intolerance[26,27,28,29,30] and is common, reported in 27% of the subjects treated with statins.[29] Statin therapy in community-dwelling older adults may exacerbate muscle performance decline and falls associated with aging without a concomitant decrease in muscle mass, a reversible effect after the cessation of statins.[31]

Most[24,26,27,28,32,33,34,35,36,37] but not all[38,39,40] recent studies have suggested that low serum vitamin D additively or synergistically interacts with statins to produce myalgia-myopathy.

Since myalgia, myositis, myopathy, and/or myonecrosis are the major causes of statin intolerance,[41] and the association of serum vitamin D deficiency, statin treatment, and myalgia, myositis, myopathy and/or myonecrosis has physiologic plausibility,[42,43,44,45,46,47] resolution of vitamin D deficiency interacting with statins to produce myalgia, myositis, myopathy, and/or myonecrosis would have significant clinical importance, allowing reinstitution of statins to optimize reduction of Low-density lipoprotein cholesterol (LDLC) and prevent cardiovascular disease.[48]

In the current study, our specific aim was determine whether and to what degree vitamin D3 supplementation of 50,000-100,000 IU/week for 6-12 months in 282 vitamin D-deficient, statin-intolerant patients was safe with regard to the development of serum hypervitaminosis D, hypercalcemia, or changes in the calculated estimated glomerular filtration rate (eGFR).

Materials and Methods

Institutional review board-approved protocol

The study followed an institutional review board-approved protocol with signed informed consent.

Statin-intolerant patients with low serum vitamin D (<32 ng/mL)

In the temporal order of their referral from Midwestern physicians (Ohio, Kentucky, Indiana, West Virginia), we prospectively studied hypercholesterolemic patients with statin intolerance (unable to tolerate ≥2 statins) who were found by us to have serum 25(OH)D <32 ng/mL, our laboratory lower normal limit. After experiencing myalgia, myositis, myopathy, and/or myonecrosis, most referred patients refused to take another statin unless steps were taken to explicate and treat[26,27,28,48] the pathoetiology of their statin intolerance.

We excluded patients who had previously developed rhabdomyolysis during statin therapy and those who were taking corticosteroids at study entry or who had comorbidities that would result in muscle or bone pain (diabetic sensory neuropathy, fibromyalgia, polymyalgia rheumatica, arthritis, peripheral vascular disease, sensory neuropathy, and hypothyroidism). Age was not used as an inclusion or exclusion criterion. After the above inclusions and exclusions, we prospectively studied 282 patients treated with 50,000-100,000 IU vitamin D3/week for 6 months, and 112 of these 282 patients for 12 months.

Laboratory determinations

At the initial visit, after an overnight fast, blood was drawn and measured for serum total 25(OH)D by LabCorp using two-dimensional liquid chromatography (HPLC) with tandem mass spectrometry detection after protein precipitation.[49] The laboratory lower normal limit for total 25(OH)D was 32 ng/mL.[49] Additional measures included plasma cholesterol, triglyceride, HDL cholesterol (HDLC), and LDLC, serum calcium, and phosphorous, along with creatine phosphokinase (CK), glucose, insulin, and renal (electronic GFR), thyroid, and liver function tests. At each follow-up visit, fasting blood was obtained for serum total 25(OH)D levels, serum calcium and phosphorous, eGFR, lipid profile, CK, glucose, and liver function tests.

Vitamin D supplementation and prospective follow-up

After documentation of low serum 25(OH)D at study entry, the 282 statin-intolerant, vitamin D-deficient patients were started on vitamin D3 by prescription[50] with 161 (57%) given ≤50,000 IU/week (median: 50,000 units/week) and 113 (40%) >50,000 IU/week but ≤100,000 IU/week (median 100,000 units/week). Only 8 patients (2.8%) were given >100,000 IU/week, with the highest dose 150,000 IU/week in 3 patients.

Patients were prospectively reassessed at 6-month intervals for 1 year [ and Figures –], with remeasurement of serum vitamin D, serum calcium, and eGFR. At each follow-up visit, a detailed history was obtained for statin and prescription drug use, and the amount of vitamin D supplementation.[48]

Table 1

Serum vitamin D, calcium, and eGFR at pretreatment entry and up to 6-month and 12-month therapies with 50,000-100,000 IU/week of vitamin D3

Serum calcium and eGFR at pretreatment entry and at the 6-month follow-up on vitamin D3 supplementation in 282 patients, median, 25^th-75^th percentiles are exhibited

Serum calcium and eGFR at pretreatment entry and at the 6-month, 12-month follow-ups on vitamin D3 supplementation in 112 patients, median, and 25^th-75^th percentiles are exhibited

Statistical methods

Based on our recent study of 146 vitamin D-deficient, statin-intolerant patients with pretreatment serum vitamin D 21 ± 7 ng/mL and levels 57 ± 19 ng/mL on supplementation,[48] power and sample size were calculated. We would have needed 24 patients before and on vitamin D supplementation to be able to observe the vitamin D treatment effect, with serum vitamin D increasing at least 20 ng/mL at a significance level of P = 0.05, with power of 80%.

Differences between pretreatment serum vitamin D, calcium, and eGFR and levels at 6 months and 12 months on vitamin D supplementation were assessed by paired Wilcoxon tests of difference. McNemar’s tests were used to check trends over time in serum calcium and eGFR (normal→abnormal or abnormal→normal).

Results

Follow-up for 6 months

As summarized in , at study entry there were 282 patients (155 men, 127 women) who had measurements of serum 25(OH)D at pretreatment entry and at 6-month follow-up. By selection, pretreatment serum vitamin D was low (<32 ng/mL) in all patients, with median levels of 21.3 ng/mL []. On 6-month follow-up on vitamin D supplementation (median 50,000 IU D3/week), median serum vitamin D rose to 46.1 ng/mL (P <.0001). Of the 282 patients, serum vitamin D levels rose into the normal range (>32 ng/mL) in 222 (79%), with 56 (20%) still low (<32 ng/mL) (median: 25 ng/mL). Serum vitamin D levels rarely rose above the laboratory upper normal limit (100 ng/mL) (n = 4, 1.4% of 282 patients, 101 ng/mL, 106 ng/mL, 140 ng/mL, 140 ng/mL) at 6-month follow-up [].

On vitamin D supplementation, no patient had serum vitamin D levels in the hypervitaminosis range (>150 ng/mL) []. On vitamin D supplementation, serum calcium was unchanged (P = .36), as was eGFR (P = .57). There was no significant trend of change in serum calcium (McNemar P = .16) or in eGFR (P = .59) from entry to 6-month follow-up [ and ].

Of the 282 patients with pretreatment serum vitamin D <32 ng/mL, 183 were unable to tolerate any statin pre-vitamin D treatment because of myalgia-myositis. At 6-month follow-up on vitamin D supplementation, 136 of these 183 patients (74%) were able to tolerate statin therapy without myalgia-myositis. Of the 99 patients taking statins at the study entry, at 6-month follow-up on vitamin D supplementation 84 (85%) continued statins without symptoms.

Sequential follow-up for 12 months

Of the 282 patients, 112 (65 men, 47 women) had both 6-month and 12-month follow-ups on vitamin D3 supplementation (median 50,000 IU/week). Median serum vitamin D rose to the normal range and remained in it []. On vitamin D supplementation, 87 of the 112 patients (78%) had serum vitamin D in the normal range (32-100 ng/mL) and 21 (19%) had serum vitamin D still low at 6 months (median 26 ng/mL). At 12 months, 87/112 (78%) patients had vitamin D in the normal range, and 24 (21%) had serum vitamin D below 32 (median 26 ng/mL). Serum vitamin D levels rarely rose above the laboratory upper normal limit (100 ng/mL) [n = 4 ng/mL, 101 ng/mL, 106 ng/mL, 140 ng/mL, 140 ng/mL, (3.6%) at 6 months, n = 1, 126 ng/mL (0.9%) at 12 months], and no patient had serum vitamin D levels in the hypervitaminosis range (>150 ng/mL) [].

At follow-up, on vitamin D3 supplementation, serum calcium was unchanged (P = .37 for month 6, P = .38 for month 12) as was GFR (P = .49 for month 6, P = .38 for month 12). There was no significant trend of change in serum calcium (P > .5) or in eGFR (P > .1) by McNemar’s test [ and ].

Of the 112 patients with pretreatment serum vitamin D <32 ng/mL, and 12-month follow-up, 82 were unable to tolerate any statin pre-vitamin D treatment because of myalgia-myositis. At 12-month follow-up on vitamin D supplementation, 74 (90%) of these 82 patients were able to tolerate statin therapy without myalgia-myositis. Of the 30 patients taking statins at study entry, at 12-month follow-up on vitamin D supplementation, 29 (97%) continued statins without symptoms.

Discussion

Low serum vitamin D is associated with statin intolerance in most studies,[26,27,28,31,32,33,34,35,36] and vitamin D3 supplementation appears to reverse statin intolerance in most studies[33,34,35,37] including our four previous reports.[26,27,28,48]

In our most recent study of 146 vitamin D-deficient, statin-intolerant patients,[48] the amount of vitamin D3 supplementation used was 50,000-100,000 units/week, and there was no adverse effect at this level of supplementation. In the current study, in a larger cohort of statin-intolerant patients with low pretreatment serum vitamin D (<32 ng/mL), with vitamin D3 supplementation of 50,000-100,000 units/week, there was no significant change in calcium levels and no significant change in eGFR. Moreover, none of the patients developed serum vitamin D levels >150 ng/mL, conventionally identified as hypervitaminosis D,[21] and very few (<4%) had serum vitamin D levels above the laboratory upper normal limit of 100 ng/mL. In the current study, vitamin D3 supplementation (50,000-100,000 units/week) for amelioration of vitamin D-dependent statin intolerance[26,27,28,48] was safe, as determined by the lack of change in serum calcium, eGFR, or development of hypervitaminosis D.

In the current study, at 6-month and 12-month follow-ups on vitamin D supplementation, 74% and 90%, respectively, of statin-intolerant patients, none of whom would take any statin at the pretreatment baseline, were able to successfully take statins.

Our finding of the safety of vitamin D3 supplementation of 50,000-100,000 units per week is paralleled by previous studies providing 11,000 units per day.[15,16] As recently summarized by Hossein-Nezhad and Holick, “…daily doses of vitamin D3 up to 10,000 IU were safe in healthy males.”[21]

Our paper is limited as it is not double-blind and placebo-controlled but this design is difficult to carry out in statin-intolerant patients who refuse, as did the patients in the current study, to try any new statin therapy without an antecedent attempt to reverse low serum vitamin D at study entry.

Overall, in our initial four reports[26,27,28,48] we have provided supplemental vitamin D3 to 402 statin-intolerant patients with low serum vitamin D at entry, of whom 352 (88%) were subsequently able to tolerate a rechallenge of statins with excellent tolerability and LDLC lowering to targeted levels.[51] The documentation of safety of 50,000-100,000 IU/week of vitamin D3 supplementation for up to 1-year follow-up as documented in the current study is important, given the utility of vitamin D supplementation as an approach to reverse statin intolerance.[48]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Safety of 50,000-100,000 Units of Vitamin D3/Week in Vitamin D-Deficient, Hypercholesterolemic Patients with Reversible Statin Intolerance

Abstract

Background:

Vitamin D deficiency (<32 ng/mL) is a reversible cause of statin-intolerance, usually requiring vitamin D3 (50,000-100,000 IU/week) to normalize serum D, allowing reinstitution of statins. Longitudinal safety assessment of serum vitamin D, calcium, and estimated glomerular filtration rate (eGFR) is important.

Aims:

Prospectively assess the safety-efficacy of vitamin D3 therapy.

Materials and Methods:

In 282 statin-intolerant hypercholesterolemic patients for 6 months and in 112 of the 282 patients for 12 months, with low-entry serum vitamin D (<32 ng/mL), we assessed safety-efficacy of vitamin D3 therapy (50,000-100,000 IU/week).

Results:

On mean (66,600 IU) and median (50,000 IU) of vitamin D3/week in 282 patients at 6 months, serum vitamin D rose from pretreatment (21—median) to 46 ng/mL (P < 0.0001), and became high (>100 ng/mL) but not toxic (>150 ng/mL) in 4 patients (1.4%). Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 at 6 months (P = .36), with no trend of change (P = .16). Median eGFR was unchanged from entry (84 mL/min/1.73) to 83 at 6 months (P = .57), with no trend of change (P = .59). On vitamin D3 71,700 (mean) and 50,000 IU/week (median) at 12 months in 112 patients, serum vitamin D rose from pretreatment (21—median) to 51 ng/mL (P < 0.0001), and became high (>100 but <150 ng/mL) in 1 (0.9%) at 12 months. Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 mg/dL and 9.60 mg/dL at 6 months and 12 months, respectively; P > 0.3. eGFR did not change from 79 mL/min/1.73 at entry to 74 mL/min/1.73 and 77 mL/min/1.73 at 6 months and 12 months, P > 0.3. There was no trend in the change in serum calcium (P > 0.5 for 6 months and 12 months), and no change of eGFR for 6 months and 12 months, P > 0.15.

Conclusions:

Vitamin D3 therapy (50,000-100,000 IU/week) was safe and effective when given for 12 months to reverse statin intolerance in patients with vitamin D deficiency. Serum vitamin D rarely exceeded 100 ng/mL, never reached toxic levels, and there were no significant change in serum calcium or eGFR.

Keywords: Deficiency, estimated glomerular filtration rate (eGFR), hypercalcemia, myalgia, myositis, hypervitaminosis D, serum calcium, supplementation, Vitamin D

Introduction

To understand the safety parameters of therapeutic vitamin D supplementation, it is important to know that 10,000-25,000 IU/day are made in the skin in response to adequate sunlight exposure.[1,2,3,4,5]

From 1934 to 1946, supraphysiological doses of vitamin D (25(OH)D) were used in the treatment of rheumatoid arthritis (200,000-600,000 IU/day),[6] 60,000-300,000 IU/day for asthma[7] and 100,000-150,000 IU/day for tuberculosis.[8] However, after months of supplementation at these doses, hypercalcemia often appeared,[6,7] with reports of resultant deaths.[9,10] Subsequently, much smaller doses of vitamin D were used to treat rickets, limited to 200 units per day.[11]

According to the Institute of Medicine, a serum 25(OH)D level of 25 ng/mL is adequate for most of the population[12] while levels >50 are high. However, much more widely used clinical normal ranges are 30-100 ng/mL[13] or 32-100 ng/mL.[4] Serum 25(OH)D of 100 ng/mL is considered by several groups to be the laboratory upper normal limit.[4,13] In treating chronic plaque psoriasis, serum vitamin D levels >50 and ranging up to 112 ng/mL were not a cause for concern.[14]

Many studies have been conducted to assess the adverse outcomes of vitamin D supplementation at various dose levels.[3,15,16,17,18,19] In normal healthy subjects, no adverse outcome was reported by Heaney et al.,[15] giving 836 IU/day, 5500 IU/day or 11,000 IU/day. Serum vitamin D levels rose from 28.1 to 64 ng/mL in 5 months in the 5,500 IU/day group, and rose to 88 ng/mL in the 11,000 IU/day group.[15] Ten thousand units/day has been proposed as a safe tolerable upper intake level, and it has been estimated that serum 25(OH)D levels >240 ng/mL would be required to result in clinically significant hypercalcemia.[16] In 2011, a community-based study with 3,667 subjects reported that dosing with 10,000 IU/day was safe, with no reported serum 25(OH)D level >200 ng/mL.[17] With 4,000 IU/day of D3 given for 1 year in two studies, no adverse effect due to vitamin D supplementation was reported,[18,19] and mean serum 25(OH)D levels after 12 months were 66ng/mL and 67 ng/mL.

In a 10-year population study, the incidence of serum 25(OH)D values >50 ng/mL increased significantly without a corresponding increase in serum calcium values or with the risk of hypercalcemia.[20] As recently summarized by Hossein-Nezhad and Holick, “serum 25(OH)D levels are usually markedly elevated (>150 ng/ml) in individuals with vitamin D intoxication,”[21] and daily doses of vitamin D3 up to 10,000 IU were safe in healthy males.[15,16]

One potential adverse outcome of high dose oral vitamin D supplementation might be the development of nephrocalcinosis but kidney stone development has not been reported for patients taking oral vitamin D3 up to 11,000 IU per day.[2,15,16,17,18,19] Moreover, there are no links reported[22,23,24,25] between oral vitamin D intake and development of kidney stones.

Statin-induced myalgia is a major cause of statin intolerance[26,27,28,29,30] and is common, reported in 27% of the subjects treated with statins.[29] Statin therapy in community-dwelling older adults may exacerbate muscle performance decline and falls associated with aging without a concomitant decrease in muscle mass, a reversible effect after the cessation of statins.[31]

Most[24,26,27,28,32,33,34,35,36,37] but not all[38,39,40] recent studies have suggested that low serum vitamin D additively or synergistically interacts with statins to produce myalgia-myopathy.

Since myalgia, myositis, myopathy, and/or myonecrosis are the major causes of statin intolerance,[41] and the association of serum vitamin D deficiency, statin treatment, and myalgia, myositis, myopathy and/or myonecrosis has physiologic plausibility,[42,43,44,45,46,47] resolution of vitamin D deficiency interacting with statins to produce myalgia, myositis, myopathy, and/or myonecrosis would have significant clinical importance, allowing reinstitution of statins to optimize reduction of Low-density lipoprotein cholesterol (LDLC) and prevent cardiovascular disease.[48]

In the current study, our specific aim was determine whether and to what degree vitamin D3 supplementation of 50,000-100,000 IU/week for 6-12 months in 282 vitamin D-deficient, statin-intolerant patients was safe with regard to the development of serum hypervitaminosis D, hypercalcemia, or changes in the calculated estimated glomerular filtration rate (eGFR).

Materials and Methods

Institutional review board-approved protocol

The study followed an institutional review board-approved protocol with signed informed consent.

Statin-intolerant patients with low serum vitamin D (<32 ng/mL)

In the temporal order of their referral from Midwestern physicians (Ohio, Kentucky, Indiana, West Virginia), we prospectively studied hypercholesterolemic patients with statin intolerance (unable to tolerate ≥2 statins) who were found by us to have serum 25(OH)D <32 ng/mL, our laboratory lower normal limit. After experiencing myalgia, myositis, myopathy, and/or myonecrosis, most referred patients refused to take another statin unless steps were taken to explicate and treat[26,27,28,48] the pathoetiology of their statin intolerance.

We excluded patients who had previously developed rhabdomyolysis during statin therapy and those who were taking corticosteroids at study entry or who had comorbidities that would result in muscle or bone pain (diabetic sensory neuropathy, fibromyalgia, polymyalgia rheumatica, arthritis, peripheral vascular disease, sensory neuropathy, and hypothyroidism). Age was not used as an inclusion or exclusion criterion. After the above inclusions and exclusions, we prospectively studied 282 patients treated with 50,000-100,000 IU vitamin D3/week for 6 months, and 112 of these 282 patients for 12 months.

Laboratory determinations

At the initial visit, after an overnight fast, blood was drawn and measured for serum total 25(OH)D by LabCorp using two-dimensional liquid chromatography (HPLC) with tandem mass spectrometry detection after protein precipitation.[49] The laboratory lower normal limit for total 25(OH)D was 32 ng/mL.[49] Additional measures included plasma cholesterol, triglyceride, HDL cholesterol (HDLC), and LDLC, serum calcium, and phosphorous, along with creatine phosphokinase (CK), glucose, insulin, and renal (electronic GFR), thyroid, and liver function tests. At each follow-up visit, fasting blood was obtained for serum total 25(OH)D levels, serum calcium and phosphorous, eGFR, lipid profile, CK, glucose, and liver function tests.

Vitamin D supplementation and prospective follow-up

After documentation of low serum 25(OH)D at study entry, the 282 statin-intolerant, vitamin D-deficient patients were started on vitamin D3 by prescription[50] with 161 (57%) given ≤50,000 IU/week (median: 50,000 units/week) and 113 (40%) >50,000 IU/week but ≤100,000 IU/week (median 100,000 units/week). Only 8 patients (2.8%) were given >100,000 IU/week, with the highest dose 150,000 IU/week in 3 patients.

Patients were prospectively reassessed at 6-month intervals for 1 year [ and Figures –], with remeasurement of serum vitamin D, serum calcium, and eGFR. At each follow-up visit, a detailed history was obtained for statin and prescription drug use, and the amount of vitamin D supplementation.[48]

Table 1

Serum vitamin D, calcium, and eGFR at pretreatment entry and up to 6-month and 12-month therapies with 50,000-100,000 IU/week of vitamin D3

Serum calcium and eGFR at pretreatment entry and at the 6-month follow-up on vitamin D3 supplementation in 282 patients, median, 25^th-75^th percentiles are exhibited

Serum calcium and eGFR at pretreatment entry and at the 6-month, 12-month follow-ups on vitamin D3 supplementation in 112 patients, median, and 25^th-75^th percentiles are exhibited

Statistical methods

Based on our recent study of 146 vitamin D-deficient, statin-intolerant patients with pretreatment serum vitamin D 21 ± 7 ng/mL and levels 57 ± 19 ng/mL on supplementation,[48] power and sample size were calculated. We would have needed 24 patients before and on vitamin D supplementation to be able to observe the vitamin D treatment effect, with serum vitamin D increasing at least 20 ng/mL at a significance level of P = 0.05, with power of 80%.

Differences between pretreatment serum vitamin D, calcium, and eGFR and levels at 6 months and 12 months on vitamin D supplementation were assessed by paired Wilcoxon tests of difference. McNemar’s tests were used to check trends over time in serum calcium and eGFR (normal→abnormal or abnormal→normal).

Results

Follow-up for 6 months

As summarized in , at study entry there were 282 patients (155 men, 127 women) who had measurements of serum 25(OH)D at pretreatment entry and at 6-month follow-up. By selection, pretreatment serum vitamin D was low (<32 ng/mL) in all patients, with median levels of 21.3 ng/mL []. On 6-month follow-up on vitamin D supplementation (median 50,000 IU D3/week), median serum vitamin D rose to 46.1 ng/mL (P <.0001). Of the 282 patients, serum vitamin D levels rose into the normal range (>32 ng/mL) in 222 (79%), with 56 (20%) still low (<32 ng/mL) (median: 25 ng/mL). Serum vitamin D levels rarely rose above the laboratory upper normal limit (100 ng/mL) (n = 4, 1.4% of 282 patients, 101 ng/mL, 106 ng/mL, 140 ng/mL, 140 ng/mL) at 6-month follow-up [].

On vitamin D supplementation, no patient had serum vitamin D levels in the hypervitaminosis range (>150 ng/mL) []. On vitamin D supplementation, serum calcium was unchanged (P = .36), as was eGFR (P = .57). There was no significant trend of change in serum calcium (McNemar P = .16) or in eGFR (P = .59) from entry to 6-month follow-up [ and ].

Of the 282 patients with pretreatment serum vitamin D <32 ng/mL, 183 were unable to tolerate any statin pre-vitamin D treatment because of myalgia-myositis. At 6-month follow-up on vitamin D supplementation, 136 of these 183 patients (74%) were able to tolerate statin therapy without myalgia-myositis. Of the 99 patients taking statins at the study entry, at 6-month follow-up on vitamin D supplementation 84 (85%) continued statins without symptoms.

Sequential follow-up for 12 months

Of the 282 patients, 112 (65 men, 47 women) had both 6-month and 12-month follow-ups on vitamin D3 supplementation (median 50,000 IU/week). Median serum vitamin D rose to the normal range and remained in it []. On vitamin D supplementation, 87 of the 112 patients (78%) had serum vitamin D in the normal range (32-100 ng/mL) and 21 (19%) had serum vitamin D still low at 6 months (median 26 ng/mL). At 12 months, 87/112 (78%) patients had vitamin D in the normal range, and 24 (21%) had serum vitamin D below 32 (median 26 ng/mL). Serum vitamin D levels rarely rose above the laboratory upper normal limit (100 ng/mL) [n = 4 ng/mL, 101 ng/mL, 106 ng/mL, 140 ng/mL, 140 ng/mL, (3.6%) at 6 months, n = 1, 126 ng/mL (0.9%) at 12 months], and no patient had serum vitamin D levels in the hypervitaminosis range (>150 ng/mL) [].

At follow-up, on vitamin D3 supplementation, serum calcium was unchanged (P = .37 for month 6, P = .38 for month 12) as was GFR (P = .49 for month 6, P = .38 for month 12). There was no significant trend of change in serum calcium (P > .5) or in eGFR (P > .1) by McNemar’s test [ and ].

Of the 112 patients with pretreatment serum vitamin D <32 ng/mL, and 12-month follow-up, 82 were unable to tolerate any statin pre-vitamin D treatment because of myalgia-myositis. At 12-month follow-up on vitamin D supplementation, 74 (90%) of these 82 patients were able to tolerate statin therapy without myalgia-myositis. Of the 30 patients taking statins at study entry, at 12-month follow-up on vitamin D supplementation, 29 (97%) continued statins without symptoms.

Discussion

Low serum vitamin D is associated with statin intolerance in most studies,[26,27,28,31,32,33,34,35,36] and vitamin D3 supplementation appears to reverse statin intolerance in most studies[33,34,35,37] including our four previous reports.[26,27,28,48]

In our most recent study of 146 vitamin D-deficient, statin-intolerant patients,[48] the amount of vitamin D3 supplementation used was 50,000-100,000 units/week, and there was no adverse effect at this level of supplementation. In the current study, in a larger cohort of statin-intolerant patients with low pretreatment serum vitamin D (<32 ng/mL), with vitamin D3 supplementation of 50,000-100,000 units/week, there was no significant change in calcium levels and no significant change in eGFR. Moreover, none of the patients developed serum vitamin D levels >150 ng/mL, conventionally identified as hypervitaminosis D,[21] and very few (<4%) had serum vitamin D levels above the laboratory upper normal limit of 100 ng/mL. In the current study, vitamin D3 supplementation (50,000-100,000 units/week) for amelioration of vitamin D-dependent statin intolerance[26,27,28,48] was safe, as determined by the lack of change in serum calcium, eGFR, or development of hypervitaminosis D.

In the current study, at 6-month and 12-month follow-ups on vitamin D supplementation, 74% and 90%, respectively, of statin-intolerant patients, none of whom would take any statin at the pretreatment baseline, were able to successfully take statins.

Our finding of the safety of vitamin D3 supplementation of 50,000-100,000 units per week is paralleled by previous studies providing 11,000 units per day.[15,16] As recently summarized by Hossein-Nezhad and Holick, “…daily doses of vitamin D3 up to 10,000 IU were safe in healthy males.”[21]

Our paper is limited as it is not double-blind and placebo-controlled but this design is difficult to carry out in statin-intolerant patients who refuse, as did the patients in the current study, to try any new statin therapy without an antecedent attempt to reverse low serum vitamin D at study entry.

Overall, in our initial four reports[26,27,28,48] we have provided supplemental vitamin D3 to 402 statin-intolerant patients with low serum vitamin D at entry, of whom 352 (88%) were subsequently able to tolerate a rechallenge of statins with excellent tolerability and LDLC lowering to targeted levels.[51] The documentation of safety of 50,000-100,000 IU/week of vitamin D3 supplementation for up to 1-year follow-up as documented in the current study is important, given the utility of vitamin D supplementation as an approach to reverse statin intolerance.[48]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Safety of 50,000-100,000 Units of Vitamin D3/Week in Vitamin D-Deficient, Hypercholesterolemic Patients with Reversible Statin Intolerance

Abstract

Background:

Vitamin D deficiency (<32 ng/mL) is a reversible cause of statin-intolerance, usually requiring vitamin D3 (50,000-100,000 IU/week) to normalize serum D, allowing reinstitution of statins. Longitudinal safety assessment of serum vitamin D, calcium, and estimated glomerular filtration rate (eGFR) is important.

Aims:

Prospectively assess the safety-efficacy of vitamin D3 therapy.

Materials and Methods:

In 282 statin-intolerant hypercholesterolemic patients for 6 months and in 112 of the 282 patients for 12 months, with low-entry serum vitamin D (<32 ng/mL), we assessed safety-efficacy of vitamin D3 therapy (50,000-100,000 IU/week).

Results:

On mean (66,600 IU) and median (50,000 IU) of vitamin D3/week in 282 patients at 6 months, serum vitamin D rose from pretreatment (21—median) to 46 ng/mL (P < 0.0001), and became high (>100 ng/mL) but not toxic (>150 ng/mL) in 4 patients (1.4%). Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 at 6 months (P = .36), with no trend of change (P = .16). Median eGFR was unchanged from entry (84 mL/min/1.73) to 83 at 6 months (P = .57), with no trend of change (P = .59). On vitamin D3 71,700 (mean) and 50,000 IU/week (median) at 12 months in 112 patients, serum vitamin D rose from pretreatment (21—median) to 51 ng/mL (P < 0.0001), and became high (>100 but <150 ng/mL) in 1 (0.9%) at 12 months. Median serum calcium was unchanged from entry (9.60 mg/dL) to 9.60 mg/dL and 9.60 mg/dL at 6 months and 12 months, respectively; P > 0.3. eGFR did not change from 79 mL/min/1.73 at entry to 74 mL/min/1.73 and 77 mL/min/1.73 at 6 months and 12 months, P > 0.3. There was no trend in the change in serum calcium (P > 0.5 for 6 months and 12 months), and no change of eGFR for 6 months and 12 months, P > 0.15.

Conclusions:

Vitamin D3 therapy (50,000-100,000 IU/week) was safe and effective when given for 12 months to reverse statin intolerance in patients with vitamin D deficiency. Serum vitamin D rarely exceeded 100 ng/mL, never reached toxic levels, and there were no significant change in serum calcium or eGFR.

Keywords: Deficiency, estimated glomerular filtration rate (eGFR), hypercalcemia, myalgia, myositis, hypervitaminosis D, serum calcium, supplementation, Vitamin D

Introduction

To understand the safety parameters of therapeutic vitamin D supplementation, it is important to know that 10,000-25,000 IU/day are made in the skin in response to adequate sunlight exposure.[1,2,3,4,5]

From 1934 to 1946, supraphysiological doses of vitamin D (25(OH)D) were used in the treatment of rheumatoid arthritis (200,000-600,000 IU/day),[6] 60,000-300,000 IU/day for asthma[7] and 100,000-150,000 IU/day for tuberculosis.[8] However, after months of supplementation at these doses, hypercalcemia often appeared,[6,7] with reports of resultant deaths.[9,10] Subsequently, much smaller doses of vitamin D were used to treat rickets, limited to 200 units per day.[11]

According to the Institute of Medicine, a serum 25(OH)D level of 25 ng/mL is adequate for most of the population[12] while levels >50 are high. However, much more widely used clinical normal ranges are 30-100 ng/mL[13] or 32-100 ng/mL.[4] Serum 25(OH)D of 100 ng/mL is considered by several groups to be the laboratory upper normal limit.[4,13] In treating chronic plaque psoriasis, serum vitamin D levels >50 and ranging up to 112 ng/mL were not a cause for concern.[14]

Many studies have been conducted to assess the adverse outcomes of vitamin D supplementation at various dose levels.[3,15,16,17,18,19] In normal healthy subjects, no adverse outcome was reported by Heaney et al.,[15] giving 836 IU/day, 5500 IU/day or 11,000 IU/day. Serum vitamin D levels rose from 28.1 to 64 ng/mL in 5 months in the 5,500 IU/day group, and rose to 88 ng/mL in the 11,000 IU/day group.[15] Ten thousand units/day has been proposed as a safe tolerable upper intake level, and it has been estimated that serum 25(OH)D levels >240 ng/mL would be required to result in clinically significant hypercalcemia.[16] In 2011, a community-based study with 3,667 subjects reported that dosing with 10,000 IU/day was safe, with no reported serum 25(OH)D level >200 ng/mL.[17] With 4,000 IU/day of D3 given for 1 year in two studies, no adverse effect due to vitamin D supplementation was reported,[18,19] and mean serum 25(OH)D levels after 12 months were 66ng/mL and 67 ng/mL.

In a 10-year population study, the incidence of serum 25(OH)D values >50 ng/mL increased significantly without a corresponding increase in serum calcium values or with the risk of hypercalcemia.[20] As recently summarized by Hossein-Nezhad and Holick, “serum 25(OH)D levels are usually markedly elevated (>150 ng/ml) in individuals with vitamin D intoxication,”[21] and daily doses of vitamin D3 up to 10,000 IU were safe in healthy males.[15,16]

One potential adverse outcome of high dose oral vitamin D supplementation might be the development of nephrocalcinosis but kidney stone development has not been reported for patients taking oral vitamin D3 up to 11,000 IU per day.[2,15,16,17,18,19] Moreover, there are no links reported[22,23,24,25] between oral vitamin D intake and development of kidney stones.

Statin-induced myalgia is a major cause of statin intolerance[26,27,28,29,30] and is common, reported in 27% of the subjects treated with statins.[29] Statin therapy in community-dwelling older adults may exacerbate muscle performance decline and falls associated with aging without a concomitant decrease in muscle mass, a reversible effect after the cessation of statins.[31]

Most[24,26,27,28,32,33,34,35,36,37] but not all[38,39,40] recent studies have suggested that low serum vitamin D additively or synergistically interacts with statins to produce myalgia-myopathy.

Since myalgia, myositis, myopathy, and/or myonecrosis are the major causes of statin intolerance,[41] and the association of serum vitamin D deficiency, statin treatment, and myalgia, myositis, myopathy and/or myonecrosis has physiologic plausibility,[42,43,44,45,46,47] resolution of vitamin D deficiency interacting with statins to produce myalgia, myositis, myopathy, and/or myonecrosis would have significant clinical importance, allowing reinstitution of statins to optimize reduction of Low-density lipoprotein cholesterol (LDLC) and prevent cardiovascular disease.[48]

In the current study, our specific aim was determine whether and to what degree vitamin D3 supplementation of 50,000-100,000 IU/week for 6-12 months in 282 vitamin D-deficient, statin-intolerant patients was safe with regard to the development of serum hypervitaminosis D, hypercalcemia, or changes in the calculated estimated glomerular filtration rate (eGFR).

Materials and Methods

Institutional review board-approved protocol

The study followed an institutional review board-approved protocol with signed informed consent.

Statin-intolerant patients with low serum vitamin D (<32 ng/mL)

In the temporal order of their referral from Midwestern physicians (Ohio, Kentucky, Indiana, West Virginia), we prospectively studied hypercholesterolemic patients with statin intolerance (unable to tolerate ≥2 statins) who were found by us to have serum 25(OH)D <32 ng/mL, our laboratory lower normal limit. After experiencing myalgia, myositis, myopathy, and/or myonecrosis, most referred patients refused to take another statin unless steps were taken to explicate and treat[26,27,28,48] the pathoetiology of their statin intolerance.

We excluded patients who had previously developed rhabdomyolysis during statin therapy and those who were taking corticosteroids at study entry or who had comorbidities that would result in muscle or bone pain (diabetic sensory neuropathy, fibromyalgia, polymyalgia rheumatica, arthritis, peripheral vascular disease, sensory neuropathy, and hypothyroidism). Age was not used as an inclusion or exclusion criterion. After the above inclusions and exclusions, we prospectively studied 282 patients treated with 50,000-100,000 IU vitamin D3/week for 6 months, and 112 of these 282 patients for 12 months.

Laboratory determinations

At the initial visit, after an overnight fast, blood was drawn and measured for serum total 25(OH)D by LabCorp using two-dimensional liquid chromatography (HPLC) with tandem mass spectrometry detection after protein precipitation.[49] The laboratory lower normal limit for total 25(OH)D was 32 ng/mL.[49] Additional measures included plasma cholesterol, triglyceride, HDL cholesterol (HDLC), and LDLC, serum calcium, and phosphorous, along with creatine phosphokinase (CK), glucose, insulin, and renal (electronic GFR), thyroid, and liver function tests. At each follow-up visit, fasting blood was obtained for serum total 25(OH)D levels, serum calcium and phosphorous, eGFR, lipid profile, CK, glucose, and liver function tests.

Vitamin D supplementation and prospective follow-up

After documentation of low serum 25(OH)D at study entry, the 282 statin-intolerant, vitamin D-deficient patients were started on vitamin D3 by prescription[50] with 161 (57%) given ≤50,000 IU/week (median: 50,000 units/week) and 113 (40%) >50,000 IU/week but ≤100,000 IU/week (median 100,000 units/week). Only 8 patients (2.8%) were given >100,000 IU/week, with the highest dose 150,000 IU/week in 3 patients.

Patients were prospectively reassessed at 6-month intervals for 1 year [ and Figures –], with remeasurement of serum vitamin D, serum calcium, and eGFR. At each follow-up visit, a detailed history was obtained for statin and prescription drug use, and the amount of vitamin D supplementation.[48]

Table 1

Serum vitamin D, calcium, and eGFR at pretreatment entry and up to 6-month and 12-month therapies with 50,000-100,000 IU/week of vitamin D3

Serum calcium and eGFR at pretreatment entry and at the 6-month follow-up on vitamin D3 supplementation in 282 patients, median, 25^th-75^th percentiles are exhibited

Serum calcium and eGFR at pretreatment entry and at the 6-month, 12-month follow-ups on vitamin D3 supplementation in 112 patients, median, and 25^th-75^th percentiles are exhibited

Statistical methods

Based on our recent study of 146 vitamin D-deficient, statin-intolerant patients with pretreatment serum vitamin D 21 ± 7 ng/mL and levels 57 ± 19 ng/mL on supplementation,[48] power and sample size were calculated. We would have needed 24 patients before and on vitamin D supplementation to be able to observe the vitamin D treatment effect, with serum vitamin D increasing at least 20 ng/mL at a significance level of P = 0.05, with power of 80%.

Differences between pretreatment serum vitamin D, calcium, and eGFR and levels at 6 months and 12 months on vitamin D supplementation were assessed by paired Wilcoxon tests of difference. McNemar’s tests were used to check trends over time in serum calcium and eGFR (normal→abnormal or abnormal→normal).

Results

Follow-up for 6 months

As summarized in , at study entry there were 282 patients (155 men, 127 women) who had measurements of serum 25(OH)D at pretreatment entry and at 6-month follow-up. By selection, pretreatment serum vitamin D was low (<32 ng/mL) in all patients, with median levels of 21.3 ng/mL []. On 6-month follow-up on vitamin D supplementation (median 50,000 IU D3/week), median serum vitamin D rose to 46.1 ng/mL (P <.0001). Of the 282 patients, serum vitamin D levels rose into the normal range (>32 ng/mL) in 222 (79%), with 56 (20%) still low (<32 ng/mL) (median: 25 ng/mL). Serum vitamin D levels rarely rose above the laboratory upper normal limit (100 ng/mL) (n = 4, 1.4% of 282 patients, 101 ng/mL, 106 ng/mL, 140 ng/mL, 140 ng/mL) at 6-month follow-up [].

On vitamin D supplementation, no patient had serum vitamin D levels in the hypervitaminosis range (>150 ng/mL) []. On vitamin D supplementation, serum calcium was unchanged (P = .36), as was eGFR (P = .57). There was no significant trend of change in serum calcium (McNemar P = .16) or in eGFR (P = .59) from entry to 6-month follow-up [ and ].

Of the 282 patients with pretreatment serum vitamin D <32 ng/mL, 183 were unable to tolerate any statin pre-vitamin D treatment because of myalgia-myositis. At 6-month follow-up on vitamin D supplementation, 136 of these 183 patients (74%) were able to tolerate statin therapy without myalgia-myositis. Of the 99 patients taking statins at the study entry, at 6-month follow-up on vitamin D supplementation 84 (85%) continued statins without symptoms.

Sequential follow-up for 12 months

Of the 282 patients, 112 (65 men, 47 women) had both 6-month and 12-month follow-ups on vitamin D3 supplementation (median 50,000 IU/week). Median serum vitamin D rose to the normal range and remained in it []. On vitamin D supplementation, 87 of the 112 patients (78%) had serum vitamin D in the normal range (32-100 ng/mL) and 21 (19%) had serum vitamin D still low at 6 months (median 26 ng/mL). At 12 months, 87/112 (78%) patients had vitamin D in the normal range, and 24 (21%) had serum vitamin D below 32 (median 26 ng/mL). Serum vitamin D levels rarely rose above the laboratory upper normal limit (100 ng/mL) [n = 4 ng/mL, 101 ng/mL, 106 ng/mL, 140 ng/mL, 140 ng/mL, (3.6%) at 6 months, n = 1, 126 ng/mL (0.9%) at 12 months], and no patient had serum vitamin D levels in the hypervitaminosis range (>150 ng/mL) [].

At follow-up, on vitamin D3 supplementation, serum calcium was unchanged (P = .37 for month 6, P = .38 for month 12) as was GFR (P = .49 for month 6, P = .38 for month 12). There was no significant trend of change in serum calcium (P > .5) or in eGFR (P > .1) by McNemar’s test [ and ].

Of the 112 patients with pretreatment serum vitamin D <32 ng/mL, and 12-month follow-up, 82 were unable to tolerate any statin pre-vitamin D treatment because of myalgia-myositis. At 12-month follow-up on vitamin D supplementation, 74 (90%) of these 82 patients were able to tolerate statin therapy without myalgia-myositis. Of the 30 patients taking statins at study entry, at 12-month follow-up on vitamin D supplementation, 29 (97%) continued statins without symptoms.

Discussion

Low serum vitamin D is associated with statin intolerance in most studies,[26,27,28,31,32,33,34,35,36] and vitamin D3 supplementation appears to reverse statin intolerance in most studies[33,34,35,37] including our four previous reports.[26,27,28,48]

In our most recent study of 146 vitamin D-deficient, statin-intolerant patients,[48] the amount of vitamin D3 supplementation used was 50,000-100,000 units/week, and there was no adverse effect at this level of supplementation. In the current study, in a larger cohort of statin-intolerant patients with low pretreatment serum vitamin D (<32 ng/mL), with vitamin D3 supplementation of 50,000-100,000 units/week, there was no significant change in calcium levels and no significant change in eGFR. Moreover, none of the patients developed serum vitamin D levels >150 ng/mL, conventionally identified as hypervitaminosis D,[21] and very few (<4%) had serum vitamin D levels above the laboratory upper normal limit of 100 ng/mL. In the current study, vitamin D3 supplementation (50,000-100,000 units/week) for amelioration of vitamin D-dependent statin intolerance[26,27,28,48] was safe, as determined by the lack of change in serum calcium, eGFR, or development of hypervitaminosis D.

In the current study, at 6-month and 12-month follow-ups on vitamin D supplementation, 74% and 90%, respectively, of statin-intolerant patients, none of whom would take any statin at the pretreatment baseline, were able to successfully take statins.

Our finding of the safety of vitamin D3 supplementation of 50,000-100,000 units per week is paralleled by previous studies providing 11,000 units per day.[15,16] As recently summarized by Hossein-Nezhad and Holick, “…daily doses of vitamin D3 up to 10,000 IU were safe in healthy males.”[21]

Our paper is limited as it is not double-blind and placebo-controlled but this design is difficult to carry out in statin-intolerant patients who refuse, as did the patients in the current study, to try any new statin therapy without an antecedent attempt to reverse low serum vitamin D at study entry.

Overall, in our initial four reports[26,27,28,48] we have provided supplemental vitamin D3 to 402 statin-intolerant patients with low serum vitamin D at entry, of whom 352 (88%) were subsequently able to tolerate a rechallenge of statins with excellent tolerability and LDLC lowering to targeted levels.[51] The documentation of safety of 50,000-100,000 IU/week of vitamin D3 supplementation for up to 1-year follow-up as documented in the current study is important, given the utility of vitamin D supplementation as an approach to reverse statin intolerance.[48]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

What Are the Effects of Taking 50,000 IU of Vitamin D Weekly?

Swordfish, salmon and tuna are rich sources of vitamin D.

Image Credit: OksanaKiian/iStock/GettyImages

Forty-two percent of the American population doesn’t get enough vitamin D, reports the director of wellness at Mercy Medical Center, Stephanie Wheeler. This nutrient, crucial for bone health, immune function and controlling inflammation in the body, is found in foods and also synthesized by the body from exposure to sunlight. If you’re deficient, taking a ​vitamin D supplement​ can help.

Fifty-thousand IU per week is well above official recommendations proposed to avoid health risks. However, it’s often prescribed in this dosage to correct vitamin D deficiencies. But should you take this amount if you don’t have a deficiency? Recent research shows that it might not be harmful and could actually be helpful for the general population.

Tip

A weekly dosage of 50,000 IU of vitamin D is almost double the tolerable upper intake level. It may or may not pose health risks.

Tolerable Upper Intake Level

The tolerable upper intake level, or UL, is the ​maximum amount of a nutrient that is safe​ for the general population to get each day on a regular basis. Above this amount, the health risks increase; the greater the excess intake, the greater the health risks, according to the National Institutes of Health (NIH).

The National Academy of Medicine (NAM) has set the UL for vitamin D at 4,000 IU, or 100 mcg, per day for all adults. Taking 50,000 IU of vitamin D each week, divided among seven days, would give you 7,143 IU each day, which is nearly double the UL.

The NAM developed the recommended daily allowance, or RDA, based on the needs of the general population. This is the amount it has determined will prevent deficiencies and the negative health effects caused by getting too little vitamin D in 97.5 percent of people.

The RDA for vitamin D for men and women, ages 19 to 70, is 600 IU daily. If you take 7,143 IU each day, that’s nearly 12 times or 1,200 percent of the RDA.

Conflicting Vitamin D Recommendations

Not everyone agrees with the National Academy’s proposed RDA and UL. Some reputable sources believe that people need well more than the RDA, and in fact more than the UL. For example, the Vitamin D Council, a California-based nonprofit, recommends adults take 5,000 IU daily or 8.3 times the RDA. People with overweight and obesity may require as much as up to 8,000 IU per day, or more than ​13 times the RDA​.

According to the Endocrine Society, the current official guidelines are based specifically on bone health but do not take into account vitamin D levels needed to prevent other conditions that may result from vitamin D deficiency. Specifically, NAM set the benchmark for deficiency at a blood level of 20 ng/ml of 25-hydroxyvitamin D, the main circulating form of vitamin D in the body. However, the Endocrine Society classifies blood levels below 29 ng/ml as insufficient and recommends a better target is 30 ng/ml or higher.

Director of the General Clinical Research Unit and Bone Health Care Clinic at Boston University Medical Center, Michael F. Holick, M.D., Ph.D., told Endocrine News, a publication of the Endocrine Society, that he believes blood levels between 40 and 60 ng/ml are an even better goal and that blood levels up to 100 ng/ml are perfectly safe.

Scientific Support: Increased Vitamin D

Research shows proponents of increased vitamin D intakes may be onto something. A 2017 study in Dermato-Endocrinology evaluated the effects of daily intakes up to 15,000 IU and blood levels up to 120 ng/ml on calcium regulation, kidney, liver and immune function. Using data collected from 3,882 participants between 2013 and 2015, the researchers found that even at blood levels of 120 ng/ml there was ​no negative effect​ on calcium regulation and no incidence of toxicity.

In a 2016 study in the North American Journal of Medical Sciences, participants took 50,000 to 100,000 IU of vitamin D per week without a significant change in blood calcium levels. Serum vitamin D levels also rarely exceeded 100 ng/ml, and there were no signs of toxicity.

According to a statistical analysis published in Nutrients in 2014, the NAM actually miscalculated its estimation of the RDA for vitamin D. In reviewing the 10 studies used by the NAM to determine the RDA, the researchers discovered that although the NAM calculated that 600 IU is the amount needed to reach serum 25-hydroxyvitamin D (25(OH)D) levels of 20 ng/ml, those calculations were ​critically underestimated​.

In fact, the studies showed that 8,895 IU might be required to meet the target blood level of 20 ng/ml. The authors conclude that the NAM’s miscalculation poses serious risks for bone health and disease and injury prevention in the general population.

There are health risks for taking too much vitamin D, but perhaps not at the levels previously suspected. Taking a 50,000 IU ​vitamin D supplement​ weekly is not likely to get you to that level. But it’s a good idea to know what these possible dangers are and at what intake and blood level the mainstream medical community says you are at risk.

​Read more:​ Symptoms of a Vitamin D Deficiency in Adults

Vitamin D is a fat-soluble vitamin, meaning any excess is stored in your fat cells. This differs from water-soluble vitamins, like the B vitamins, which get carried out in urine and need to be replaced each day. Excess fat-soluble vitamin intake can lead to a buildup of the nutrient in your body, which, over time, can be toxic, according to the NIH. Excess ​vitamin D side effects​ include:

• Anorexia
• Weight loss
• Frequent urination
• Heart arrhythmia

More seriously, excess intake can increase blood levels of calcium, which can cause vascular and tissue calcification. This can damage the heart, blood vessels and kidneys.

Long-term intakes of 10,000 to 40,000 IU daily and consistent blood levels of 200 ng/ml or greater are considered to be potentially toxic. According to the NIH, intakes below 10,000 IU daily aren’t likely to cause toxicity symptoms.

Other Potential Negative Effects

But toxicity may not be the only thing to worry about. Even at lower intakes, as low as 30 to 48 ng/ml, the NIH reports potential risks including increased all-cause mortality, greater risk of some cancers, such as of the pancreas, increased risk of cardiovascular events, and a higher incidence of falls and fractures among the elderly.

These conflicting recommendations and data pose a dilemma for the consumer. A daily intake of 7,000 IU is highly unlikely to cause vitamin D toxicity and very unlikely to cause other problems. However, there’s no way to be sure.

If you think you may be deficient in vitamin D, see your doctor for a ​blood test​. Get her expert advice on the right blood level. If testing shows you are below this level, then follow your doctor’s recommendation for how much vitamin D to take each day.

Food, Sunlight and Supplements

There’s no risk of toxicity from vitamin D in foods or excess exposure to sunlight. It is only caused by taking excessive amounts of ​vitamin D pills​ over a period of time. If you don’t have a deficiency requiring medical treatment, you may be able to hedge your bets by getting more D from natural sources.

When you spend time outdoors, ultraviolet B radiation (UVB) penetrates the skin, which converts it to a substance called cutaneous 7-dehydrocholesterol, then to previtamin D3 and finally to vitamin D3. Many factors affect how easily your body creates the vitamin: the season, the time of day, the length of the days where you live, the amount of melanin your skin produces, smog and cloud cover and sunscreen among them. Therefore it’s not a good idea to rely on getting everything you need from sun exposure.

Furthermore, organizations like the Skin Cancer Foundation and the American Academy of Dermatology caution that there is no such thing as safe sun exposure. According to Anne Marie McNeill, MD, PhD, and Erin Wesner, not using sunscreen increases your risk of squamous cell carcinoma, melanoma and premature skin aging.

It doesn’t take a lot of sun exposure for your skin to make vitamin D. About 10 to 15 minutes on the legs, arms, abdomen and back is more than enough. However, McNeill says even that amount of sun exposure can cause dangerous DNA damage, and she recommends protecting your skin with SPF 15 or higher whenever you venture outdoors.

A better way to get your D is through a healthy diet. According to the NIH, very few foods naturally contain vitamin D; however, there are a few very rich sources, including:

• Swordfish: 566 IU per 3 ounces
• Sockeye salmon: 447 IU per 3 ounces
• Tuna in canned water: 154 IU per 3 ounces
• Beef liver: 42 IU per 3 ounces
• One large whole egg: 41 IU
• Sardines canned in oil: 46 IU in two sardines

Other commercially prepared foods are often fortified with vitamin D. Some examples include:

• Orange juice: 137 IU per cup
• Milk: 115 to 124 IU per cup
• Yogurt: 80 IU per 6 ounces

Regularly including these foods in your diet can often help you get all the vitamin D you need without sun exposure or a supplement.

Not getting adequate vitamin D can also have serious consequences. In its role as a hormone, vitamin D aids the regulation of more than 200 genes in the body. Some of the jobs vitamin D is responsible for include preventing the multiplication of abnormal cells in breast and colon tissue and helping to regulate blood pressure in the kidney and blood sugar in the pancreas.

Additionally, Erin Michos, M.D., M.H.S., reports that there is a strong connection between vitamin D deficiency and an increase in risk of heart attack, congestive heart failure, peripheral arterial disease (PAD), stroke, high blood pressure and diabetes.

​Read more:​ 9 Ways to Help Avoid Vitamin D Deficiency

For certain people, getting more than the established RDA may be especially important, according to MedlinePlus. These include older adults whose kidneys aren’t as good at converting vitamin D to its active form, people with darker skin colors, people with digestive disorders such as Crohn’s or celiac disease, people with obesity, those with chronic kidney or liver disease and people with lymphomas. These people should be sure to have ​their blood levels tested​ regularly and to adhere to their doctor’s recommendations for diet and supplementation.

Why Did My Doctor Prescribe 50,000IU Of Vitamin D?

A Robust Supplement

A Robust Supplement
A supplement containing 50,000IU of vitamin D can sound like a huge amount. Most general recommendations advise people to supplement with 400-800IU of vitamin D. In what cases might a doctor prescribe such a high amount of vitamin D?

Why is vitamin D important?

Also called the sunshine vitamin, this nutrient is critical for building strong bones and maintaining a healthy immune system. Deficiency in this vitamin has been linked to depression, muscle weakness, high blood pressure, and the risk of certain cancers. Especially in areas of the country that regularly have overcast weather, vitamin D deficiency can be a common problem.

Higher amounts of supplementation

For the majority of the population, a daily intake of 400-800IU of vitamin D is adequate. Even on the high end, this would only equal about 5,000IU weekly. However, some research has shown that some patients who are vitamin D deficient may need up to 50,000IU weekly to reach normal ranges.

Who is at risk?

Vitamin D deficiency is more common than many people realize. Around 1 billion people worldwide are deficient in the nutrient. People who are at risk of vitamin deficiency include those who live in climates that don’t get a lot of sun and people who eat a diet low in the nutrient, such as a vegan diet. At-risk patients can also include those who have health conditions that prevent proper nutrient absorption. Older patients and those with dark skin pigmentation are also in the high-risk group.

Specific conditions

Some health conditions are directly linked to a nutrient deficiency. For example, one study showed that people who had adequate levels of the vitamin were at a 62% lower risk of developing multiple sclerosis. Celiac disease, Crohn’s disease, and cystic fibrosis can all interfere with vitamin absorption. People with any of these specific health conditions may get a prescription for a particularly robust vitamin D supplement.

Testing nutrient levels

Patients should get a blood test from a healthcare provider to find out where nutrient levels are at before starting any supplement. Too much vitamin D can lead to loss of appetite, nausea, vomiting, fatigue, dizziness, excessive thirst, and frequent urination. These symptoms are not just uncomfortable but can also be a threat to a person’s health. People should avoid taking supplements unless advised by a healthcare provider.

Find out more

Though vitamin D deficiency is common, all patients should consult with a healthcare provider before starting a supplement. A healthcare provider can test a patient’s current nutrient levels and provide recommendations for treatment.

90,000 Doctors: lack of vitamin D leads to severe forms of COVID-19

Vitamin D deficiency leads to a more severe course of COVID-19, British doctors warn. To avoid complications, it is necessary to take vitamin D in shock doses – despite the fact that this can lead to an excess of calcium in the body, experts are sure.

Vitamin D deficiency may cause more severe COVID-19, according to doctors from Imperial College London. The study has not yet been published, the authors told the newspaper Express about it.

“Under normal circumstances, reviewing and publishing can take up to a year,” explains Garrett Davis, one of the researchers. “And we have been suffering from a pandemic for a year.”

The authors of the work found “a striking correlation between the severity of COVID-19 and latitude”: – In the Northern Hemisphere, where seasonal vitamin D deficiency is common, there were more severe cases of the disease.

Vitamin D deficiency is the dominant risk factor for COVID-19, Davis said.

Vitamin D plays a role in the functioning of the immune system, promoting its activation in response to bacteria and viruses entering the body.When vitamin D levels are normal, immunity works more efficiently, the researchers explain.

“The virus targets a protein spike on the surface of cells called ACE2, which is part of the renin-angiotensin system (RAS),” says Davis. “Among other things, the RAS regulates blood pressure and the inflammatory response.”

During replication, the virus can deplete ACE2, causing a cytokine storm – uncontrolled inflammation that damages the body’s own tissues.

Vitamin D deficiency cannot be prevented.

“This is what kills people,” emphasizes Davis.

According to the recommendations of doctors, in October-March, adults should receive 400 IU (10 mcg) of vitamin D per day with food or supplements. However, Davis insists that the amount should be increased to 4000 IU (100 mcg).

Recommended doses of vitamin D do not “protect the immune system from infection and disease,” Davis said.

At the same time, you should not be afraid of hypercalcemia, says Davis – it is rare and treatable.In addition, the risk of hypercalcemia is incomparably lower than the risk of dying from COVID-19, he said.

Excess calcium in the body can worsen bone health and damage the kidneys and heart. However, Davis is convinced that 4,000 IU of vitamin D is absolutely safe for adults. Only children and underweight adults should reduce the dosage.

“Vitamin D supplementation should be the number one tactic in global pandemic strategies,” Davis concludes. “We know that vitamin D reduces the risk of infection and stops the development of serious illness in most people.”

Earlier, US researchers also drew attention to the protective function of vitamin D. They referred to a number of studies linking vitamin D levels and the course of respiratory diseases. In particular, the risk of suffering from lung disease increased as the concentration of vitamin D in the blood decreased. The researchers suggested that this indicator may affect the course of COVID-19.

Scientists have measured the level of vitamin D in the blood of 235 patients aged 20-90 years who were admitted to hospital with COVID-19.They also assessed the severity of symptoms (breathing problems, hypoxia, loss of consciousness, etc.) and the risk of death. In addition, the levels of lymphocytes and inflammation biomarkers were measured.

As it turned out, in patients over 40 years of age with sufficient levels of vitamin D, the probability of death from coronavirus was 51.5% lower than in patients with its deficiency.

The norm for vitamin D content is considered to be about 30 ng / ml. This level was observed in only one third of patients.

The concentration of vitamin D had little effect on the level of lymphocytes, but it was lower in patients with vitamin D deficiency.There was no significant difference in the length of hospital stay. However, at normal vitamin D levels, patients were less likely to experience loss of consciousness and hypoxia.

The authors of the work believe that the role of vitamin D in the fight against COVID-19 is associated with its effect on the immune system and the formation of acquired immunity. Also, the anti-inflammatory function of vitamin D may be associated with a lower risk of developing a cytokine storm.

90,000 Coronavirus: why vitamin D is important in quarantine and what it is eaten with

April 24, 2020

Photo author, Getty Images

Photo caption,

Vitamin D intake is especially important during quarantine, experts say

Health Department England has recommended taking vitamin D daily in the spring and summer while the quarantine continues.

We usually get enough of it by spending time outdoors as it is produced when exposed areas of our skin are exposed to sunlight.

It is also called the “vitamin of the sun” and, along with some others, it helps our body fight infections, which is especially important during the current pandemic.

Who benefits from taking vitamin D?

Recommendations

Even before the outbreak of the coronavirus epidemic, Britons were advised to take 10 mcg of vitamin D daily during the winter months (October to March) or year-round if they don’t spend enough time outdoors.

However, in the current situation, when everyone is prescribed to stay at home, the lack of this important vitamin may begin to be felt more acutely.

British experts recommend taking vitamin D in tablets or capsules all year round:

• if you hardly ever go outside, for example, if you have to take care for health reasons (after heart surgery, undergoing serious illnesses, etc.)
• If you live in a nursing home
• If you usually wear closed clothes when you go outside

People with dark complexions may also lack the “sunshine vitamin” even if they regularly spend some time outdoors.

Photo author, Getty Images

Photo caption,

Experts say vitamin D has anti-inflammatory effects on the body

The Scottish and Wales authorities have issued the same recommendations.

“Unfortunately, as the coronavirus continues to affect our lives, many of us spend very little time outdoors,” says Sarah Stanner of the British Dietetic Foundation. many of us do not get enough sunlight, which means that we must make sure that the body is not deficient in vitamin D. “

Why do we need vitamin D?

Vitamin D strengthens teeth, bones and muscles.

Its lack in early childhood can cause rickets – underdevelopment of bones and deformation of the skeleton, and in adults – osteomalacia, softening of bones due to insufficient mineralization, the so-called “adult rickets”.

According to some studies, this vitamin helps us fight common colds and flu, although there is no reliable evidence that vitamin D boosts immunity.

Several studies have linked low vitamin D levels to seasonal depression. There is even evidence that a lack of this vitamin can affect the functioning of the nervous system and mental health.

Can I take it in large doses?

Don’t do that. Although vitamin D supplements are quite harmless, if taken daily and in large quantities, it can be harmful in the long term.

Safe doses are as follows:

• children aged 1 to 10 years – no more than 50 mcg per day
• infants under 12 months – no more than 25 mcg per day
• adults – no more than 100 mcg per day, and as part of dietary supplements – 10 mcg per day

In some cases, if the patient is diagnosed with vitamin D deficiency, the doctor may prescribe higher doses.

Vitamin D is not recommended for certain diseases, such as kidney disease.

Can it protect against coronavirus?

No, it cannot. There is no evidence that this vitamin somehow protects against coronavirus infection.

Nevertheless, experts believe that during a pandemic, it is not useless.

Vitamin supplements containing vitamin D will improve the well-being of those who lack it in the body.

Some experts see a relationship between a lack of vitamin D in the body and a more severe course of the disease in the case of coronavirus infection. At the same time, such patients often have other reasons for complications, so it is still difficult to draw an unambiguous conclusion here.

Spanish and French doctors are now conducting clinical trials to see if vitamin D helps patients with coronavirus infection.

As pointed out by the British professor of medicine John Rhodes, vitamin D has anti-inflammatory properties.

In addition, as evidenced by some studies, it can somewhat suppress the body’s immune response to viruses.

This may be important for those critically ill patients with coronavirus in whom viral pneumonia of the lungs causes a cytokine storm – an acute reaction of the immune system. However, as Professor Rhodes points out, little is known about this relationship.

D2 or D3 and how much do you need?

Vitamin D tablets or capsules, alone or in multivitamins, sold in pharmacies, supermarkets and health food stores.For babies, vitamin D comes in drops.

Experts remind that it is not necessary to buy immediately into stock, so as not to create a deficit.

In most cases, this vitamin is indicated on the packaging as D2 or D3.

The difference is that D2 (ergocalciferol) is synthesized from plants, and D3 (cholecalciferol) – by ultraviolet radiation, that is, in the same way as it happens in our body.

Studies have shown that the D3 form is more effective, so the recommendation is more likely to lean in its favor.

Is it enough in food?

Photo author, Getty Images

Photo caption,

There is little vitamin D in food, but some manufacturers add it to their products, for example, in breakfast cereals

Despite its name, vitamin D is actually a hormone. which is responsible for the absorption of calcium by the body.

It is almost nowhere else, except in fatty fish and eggs, but under the influence of ultraviolet rays, our skin produces its own hormone from ordinary cholesterol.

Some manufacturers add the synthesized vitamin to yoghurts, breakfast cereals and margarine.

How to understand that it is missing?

“The need for sunlight in the summer months is very individual and depends on both the color of the skin and the amount of fat in the body, and how quickly the body builds the skeleton. It is a very complex process,” says medical historian Robert Bivney of Warwick university.

That is why it is necessary to determine whether you have enough vitamin D in your body, not by symptoms, but with the help of a blood test.

Would you like to sunbathe?

It is impossible to get too much vitamin D while sunbathing, but getting a burn is likely, so it is important not to overdo it and protect your skin from burns with sunscreen or clothing.

What should children and pregnant women do?

Medical recommendations are as follows:

• children from birth to 1 year old should receive 8.5-10 μg of vitamin D daily
• Infants who are bottle-fed do not need to give any supplements, since the infant formula already contains vitamin D – but only up to as long as they do not receive less than 500 ml of infant formula per day
• children from 1 to 4 years old should receive 10 mcg per day
• pregnant and lactating women should also receive 10 mcg per day

Than us treated: vitamin D.To drink or not to drink?

Exceptions to the rules

The higher the bar for the elderly is explained by the fact that their skin gradually loses its ability to replenish the required amount of vitamin in the light. Also, a deficiency is more threatening for dark-skinned people, since melanin reduces the skin’s permeability to ultraviolet radiation, without which the synthesis of the vitamin will not pass.

More vitamin D is also required for people with a body mass index over 30. The fact is that fat can accumulate and retain vitamin in itself, interfering with its metabolism in the body.Therefore, in order to achieve normal blood counts, they have to take more supplements.

Vegetarians (and those on other diets), people with lactose intolerance or allergies to milk proteins are also at increased risk of vitamin D deficiency. For pregnant and lactating women, the amount of many vitamins taken, at first glance, should be higher. Surprisingly, the WHO does not recommend them any high doses of vitamin D – it just advises them to eat properly and bask in the sun (without specifying how much, since it depends on the latitude, openness of clothes, skin tone and other factors).However, they note that for infants with rickets, vitamin D supplements given by the mother may be beneficial, although there are no plans to introduce this into widespread practice.

How to determine the deficiency

Since your personal norm, as we found out, can be different, and the signs of the initial stages of vitamin deficiency are quite general, the analysis will help you understand what you are missing. The best option to calm your conscience is a laboratory test for the level of 25-hydroxycalciferol in the blood.Calciferol is vitamin D, so don’t be intimidated by the name. Even the test itself is sometimes called “25-hydroxyvitamin D”, or “25 (OH) D”. Do not smoke 30 minutes before the test, and do not eat for 4 hours before.

In order not to get confused in the units of measurement, you can use converters, such as this one. The norm for both a child and an adult will be 30–100 ng / ml. For a child, a value below 10 ng / ml will be a sign of rickets. If 25-hydroxycalciferol in the blood is more than 150 ng / ml, then there is a possibility of an overdose.By the way, an excess of vitamin does not lead to good either. We remember that it is involved in calcium metabolism, so it is not surprising that too much of it increases the risk of kidney stones in older women, and 200 ng / ml or more can be toxic at all – if not with a single dose, then in the long term. perspective.

But every time you think about vitamin D supplements, you need to understand that medicine should not treat tests, but the patient. If the indicators deviate from the generally accepted norm, but this does not manifest itself clinically, in many cases it makes no sense to correct them: perhaps for this organism the value of the norm is somewhat biased, and it will be more comfortable for him to live with just such indicators.Therefore, it is thankless to interpret the test results in isolation from the clinical picture.

what is it for and does it help against viruses, irradiators of open and closed type, ozone and ozone-free

Daniil Davydov

medical journalist

Author’s profile

Ultraviolet germicidal lamps are essential in operating rooms and may be useful in hospital wards.

But in a house where an ordinary family lives, germicidal lamps are unlikely to prevent infection.

See your doctor

Our articles are written with a passion for evidence-based medicine. We refer to reputable sources and go for comments from reputable doctors. But remember: the responsibility for your health lies with you and your doctor. We do not write prescriptions, we make recommendations. It is up to you to rely on our point of view or not.

What is a germicidal lamp and what is it for

Bactericidal lamp – a device for inactivating viruses and destroying bacteria and mold.Such a lamp works thanks to ultraviolet radiation.

What are germicidal lamps – FDA Bulletin

However, not all commercially available UV lamps are suitable for room disinfection. To understand how UV lamps differ from each other, let’s first understand why certain types of light are generally capable of killing microbes.

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How ultraviolet light affects living organisms

Light sources such as the sun, fire and incandescent bulbs emit particles called photons, which carry different amounts of energy.How much energy the photons had depends on how they behave when they collide with a living being – it doesn’t matter whether it is a microbe or a person.

Streams of photons, the energy of which is enough to activate light-sensitive proteins in our eyes, we call visible light. When they collide with the skin, some of these photons are reflected from it, and some are absorbed. The absorbed photons transfer a little bit of energy to the complex molecules that make up skin cells. But this energy is too small to change the structure of molecules, so visible light does not harm the skin, eyes, or other parts of the body in any way.

Streams of photons, which have more energy than visible light, do not activate light-sensitive proteins in the eyes, so we cannot see them. In this case, photons with a large amount of energy penetrate deeper into the skin than photons from visible light, and transfer a lot of energy to the molecules of which it is composed.

How do light, infrared and ultraviolet radiation interact with the skin and eyes? – Scientific Committee opinion on emerging and recently identified health risks

Ultraviolet rays do not activate light-sensitive proteins in our eyes, so we cannot see them

Invisible rays with a large amount of energy include ultraviolet radiation, X-rays and gamma radiation – in other words, radiation.Of the entire set of invisible rays, ultraviolet radiation has the least energy. Commercially available germicidal lamps can only produce ultraviolet light.

What is ultraviolet radiation – WHO bulletin

Part of the ultraviolet energy activates the proteins responsible for the formation of vitamin D. But if a person receives too high a dose of ultraviolet radiation, this turns into a problem.

The fact is that DNA molecules – the material of which genes are made – absorb ultraviolet rays very easily.The energy that photons share with DNA triggers photochemical reactions that destroy these molecules. Therefore, if a person spends a lot of time in the sun without sunscreen, the structure of DNA in his skin cells is disrupted. Over time, this can lead to melanoma, or skin cancer.

High doses of ultraviolet radiation cause skin cancer – bulletin of the British charity “Cancer Research”

Ultraviolet affects the genetic material of pathogenic viruses and microbes approximately the same as on humans, only much stronger.After all, representatives of our species are protected by thick skin, and viruses and bacteria have only thin membranes or cell walls.

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Why not all UV lamps are germicidal

Conventional light bulbs remove ultraviolet waves from the emitted spectrum. This is to ensure that people who turn on the lights at home and at work do not get skin cancer.

Unlike household bulbs, ultraviolet lamps are needed precisely in order to generate as much ultraviolet rays as possible. To understand which ultraviolet lamps can disinfect a room and which cannot, you need to understand their main characteristic – wavelength.

Efficacy of Ultraviolet Germicidal Lamps in Fighting Infections – Report of the Committee of the Light Engineering Society PDF, 684 KB

All lamps, both conventional and bactericidal, emit streams of photons that propagate in the air as waves.The length of such waves is usually measured in nanometers, or nm, – this is one billionth of a meter.

The longest waves we can see are red and the shortest are purple. Due to the fact that visible light with different wavelengths activates visual proteins in slightly different ways, we see a rainbow and distinguish colors.

UV radiation, which lies outside of visible light, also has its own rainbow, that is, it consists of shorter and more authentic waves. The shorter the wavelength of UV radiation, the more energy it carries.That is why lamps emitting ultraviolet light with different wavelengths have different properties.

Unlike a normal rainbow, an ultraviolet rainbow is invisible. So the colors with which it is marked on the diagram are conditional

In practice, people use three types of ultraviolet lamps.

Shortwave emitters. Generates ultraviolet UV-C waves with a wavelength of 100-280 nm. These are the most photochemically active ultraviolet rays, which most rapidly destroy genetic material, depriving viral particles of infectiousness and killing bacteria. The principle of operation of all medical and household germicidal lamps is based on this property of UV-C rays.

UV-C with a wavelength of 100-280 nm is almost completely absorbed by the epidermis – the surface layer of dead cells, so that these rays hardly penetrate into the deep layers of the skin. However, if you are under such a lamp for more than eight hours every day, ultraviolet light can still damage the genetic material of cells and provoke cancer.

In addition, UV-C can cause eye burns, which will only heal in a day or two.Therefore, during the treatment of the room with ultraviolet light, there should be no people, no animals, no plants.

Medium wave emitters. Generates ultraviolet UV-B waves with a wavelength of 280-315 nm. UV-B rays can also kill germs and viruses, but they do so more slowly and not as effectively as UV-C rays.

Emitters with UV-B rays can cause artificial tanning, therefore they are installed in tanning salons. But it is important to remember that these rays carry a lot of energy and at the same time penetrate deeper into the skin than UV-C rays, that is, they are capable of destroying the genetic material in the skin cells.Therefore, visiting a solarium is generally not recommended.

UV-B lamps can also be used for medical purposes. Therapeutic ultraviolet lamps are used to combat skin cells affected by psoriasis, lupus erythematosus, atopic dermatitis, vitiligo and fungus. But if you spend too much time under UV-B rays, healthy skin cells will also begin to break down. Therefore, curative UV-B lamps are used only in hospitals, under the strict supervision of a physician. There are no household UV-B emitters.

Long-wavelength emitters. Generates ultraviolet UV-A waves with a wavelength of 315-400 nm. In principle, UV-A rays are not capable of destroying viruses and are about a thousand times less effective against bacteria and fungi than UV-C rays. They are not suitable for disinfection of premises.

These lamps are also not used in medicine. The benefit of UV-A lamps is that they can detect phosphors – substances that can convert ultraviolet radiation into ordinary light visible to the naked eye.Phosphors are found in pet urine, human tooth enamel, paint used to mark genuine banknotes, and bleach particles that remain on clothes after washing. Therefore, such lamps are used for finding urine stains, checking the authenticity of banknotes and for lighting in nightclubs.

And UV-A lamps also polymerize, that is, they make some types of varnishes and paints solid, so they are used for drying nails and making crafts.

Although some manufacturers promote UV lamps that generate UV-A light as germicidal, there is no evidence that this actually works.

UV-A radiation penetrates the skin even deeper than UV-B rays. It is believed that this radiation does not damage the genetic material in cells and does not provoke cancer, but it can damage the connective tissue in its depths. This leads to the appearance of wrinkles, age spots and premature aging of the skin. Therefore, it is not recommended to be in the room where the UV-A lamp is working daily for more than three hours in a row.

How germicidal lamps work

All ultraviolet germicidal lamps are shortwave, that is, they generate ultraviolet UV-C waves.The easiest way to construct a germicidal lamp that generates ultraviolet radiation with a wavelength of 253.7 nm.

Bactericidal sources and systems of UV radiation – journal “Photochemistry and Photobiology”

The wavelength, lethal for viruses and microbes, is 265-270 nm. And since the wavelength of 253.7 nm is close to these indicators, household and medical germicidal lamps with this characteristic are most common.

The most popular design of germicidal lamps is low pressure mercury lamps.In appearance and principle of operation, they are very similar to ordinary fluorescent lamps that can be found in the corridors of offices and hospitals.

Since the task of a germicidal lamp is to generate ultraviolet radiation, not visible light, there is no phosphor on the walls of its bulb. On the contrary, the flask itself is made of special quartz glass, which transmits UV-C rays well. Therefore, such lamps are often called quartz lamps, and the process of irradiating a room itself is quartz.

Has germicidal lamps been proven to be effective

The ability of germicidal lamps to destroy pathogens is highly dependent on the type of lamp, installation method and time of exposure to viruses and microbes.Therefore, they need to be assessed separately, taking into account the design and the purpose for which they are used.

Efficacy of Ultraviolet Germicidal Lamps in Fighting Infections – Report of the Committee of the Light Engineering Society PDF, 684 KB

All germicidal lamps can be divided into two large types: open and closed.

Open source is a mercury lamp that emits ultraviolet light. Such a lamp is capable of disinfecting both the surfaces that UV rays reach and the air in the room.To prevent UV-C rays from causing harm to the skin and eyes, you must leave the room while the lamp is on.

Tabletop open-type irradiator. Price: 2800 R. Source: “Ozone” An open type irradiator, which must be fixed on the wall or on the ceiling, like an ordinary lamp. Price: 790 R. Source: “Ozone”

Theoretically, one 30-watt UV-C germicidal lamp with 11.2 watts of UV-C radiation takes 15 minutes to half an hour to destroy viruses and bacteria on the floor, walls and ceiling of a standard one-room apartment with an area of ​​36 m2 ² .But in practice, two serious problems immediately arise.

First problem – UV-C rays do not pass through the dust and do not enter the crevices. UV-C rays penetrate shallowly not only into human skin, but also into any other surface. If bacteria, viruses and fungi are found even under the thinnest layer of dust or deep in small cracks on the surface of wooden tables or dishes, germicidal lamps will not cope with them.

UV-C lamps are best at killing germs on perfectly clean and level surfaces such as a metal table, tray or surgical instruments.But if we are not talking about an operating room, but about an ordinary apartment, which is cleaned once or twice a week, then the dust will almost certainly be there. This immediately drastically reduces the benefits of UV treatment.

In order for the sterilizer to cope with germs, the phone will first have to be wiped with an alcohol-based cleaning fluid or sanitizer. But a sanitizer based on 60-70% ethyl alcohol already kills all bacteria and viruses, except for hepatitis A and polio.Why use a sterilizer as well is unclear.

Second problem – UV-C rays do not work in the shade. Ultraviolet light can kill germs only if it gets on them. Even if you fix the lamp on the ceiling, there will always be shaded corners in the room, into which ultraviolet light will not reach. In addition, UV-C rays do not penetrate behind cabinets and under beds, so you cannot rely on them to fight germs.

This is why hospital staff at do not rely on exposed UV lamps as an effective way to combat viruses and germs on walls and objects. Ultraviolet is used only as an additional method of disinfection, coupled with cleaning with antiseptics.

Guidance on the Use of Ultraviolet Germicidal Radiation for Air Disinfection – Bulletin of the American Society of Heating, Refrigerating and Air-Conditioning Engineers PDF, 1.02 MB

The most important role that open irradiators play in hospitals and offices is air disinfection. For this purpose, germicidal lamps are installed on the ceiling and placed in hoods and air ducts through which fresh air enters the room.This air purification system is called combined.

In this situation, the germicidal lamps on the ceiling are turned on for 15-30 minutes when there are no people in the room, and the lamps in the hoods and air ducts work around the clock, even when people are in the room. With this air treatment mode, germicidal lamps really reduce the risk of infection.

But if you limit yourself to only a desktop or ceiling irradiator and turn it on for half an hour a day, there will be little benefit from treating the room.At the speed with which the air is mixed in an ordinary city apartment, for effective disinfection, not only half an hour, but also a whole day will most likely not be enough. This means that the open-type home germicidal lamp is useless. And if it is still on the table, it can be harmful. If a person enters the room who does not know about the lamp, it can cause eye burns.

Closed irradiator, or recirculator, – lamp insulated with a special cover that does not let ultraviolet light into the room.There is a fan inside the cover that sucks air into the lamp. Since ultraviolet light does not leave the lamp, a closed irradiator disinfects only air. But while he is working, people and pets can be in the room.

Floor-standing portable bactericidal irradiator for hospitals, 66 cm high. Price: 12,000 R. Source: “Russian Caliber” Household radiator measuring 30 cm. The smaller the irradiator, the less efficient it works. Price: 3999 R. Source: Ozone

It would seem that closed irradiators should solve the problem, because they can work in the presence of people.But even large, portable, enclosed irradiators with powerful built-in fans, used in hospitals and offices, let air through them 6 to 12 times slower than needed for effective disinfection. While they reduce the number of pathogenic viruses and bacteria in the air, members of the Light Engineering Society’s committee believe that this is happening too slowly to prevent transmission of infection and protect people from infection.

Closed-type household irradiators are much smaller than hospital irradiators and have a weaker fan.This means that they disinfect the air even more slowly. It is not necessary to expect that they will be more effective than hospital irradiators.

Why germicidal lamps with ozone are dangerous

Many manufacturing companies are well aware that their irradiators are not efficient enough. Therefore, some of them advertise dual-action emitters, that is, devices that produce both ultraviolet and ozone. But in reality, the ability to produce ozone is more of a disadvantage than an advantage.

When an electric current passes through argon saturated with mercury vapor, the tube produces mainly ultraviolet radiation with a wavelength of 254 nm. In this case, a certain amount of radiation with a wavelength of 185 nm appears.

Shortwave radiation reacts with oxygen from the air to form ozone, a gas made up of three oxygen molecules. Its presence in the air can be easily detected by its characteristic smell immediately after a thunderstorm.

What is Ozone – US EPA Bulletin

Ozone very easily reacts with the molecules that make up bacteria and viruses, therefore it is theoretically capable of disinfecting the air.But it only works at very high concentrations.

After a thunderstorm, the concentration of ozone in the air is 0.02 parts per million air molecules, or 0.02 million ^-1 . It is safe for human health and harmless to viruses and bacteria.

Safe and effective use of ozone as a disinfectant for air and surfaces – Gases magazine PDF, 443 KB

In order for the gas to be guaranteed to destroy pathogens, its concentration must be significantly higher.Which one depends on how much time is supposed to be spent on processing the premises. When the concentration of gas in the air is 10-20 million ^-1 ozone kills viruses and bacteria in ten minutes. And at a concentration of 0.6 million ^-1 – in two hours.

The problem is that when the concentration of ozone in the air exceeds 0.02 million ^-1 , the gas begins to irritate the throat and provoke a cough. Some factory workers who are constantly breathing ozonized air even develop asthma due to constant exposure to ozone.

This means that ozone in the composition of the emitter is not only useless, but also harmful to health. During the operation of the ozone emitter, you cannot be in the room – and it does not matter what type of this emitter, open or closed. And after he works, the room will have to be ventilated.

Closed-type ozone irradiator. Price: 8950 R. Source: “Ozone” Ozone irradiator of open type. Price: 999 R. Source: Ozone

Do I need a germicidal lamp at home

Household open-type germicidal lamps have three major drawbacks that far outweigh their potential benefits:

1. UV-C rays are harmful to the eyes.If a person forgets that the radiator is on in the room and looks at it while he is working, there is a serious risk of corneal burns. If a cat, dog or guinea pig accidentally looks at the lamp, they will also damage the eyes.
2. UV-C rays are harmful to plants. Therefore, before processing the room, all homemade greens must be transferred to another room, and this is inconvenient.
3. UV-C rays damage paint and plastics. If you turn on the household germicidal irradiator in the room every day, repairs will soon have to be updated.

In an empty and tiled medical office, an open irradiator is a useful thing. At home – not very much.

At the same time, closed-type germicidal lamps, if they do not emit ozone, are safe for health. Some organizations, such as the Committee of the Light Engineering Society, advise purchasing such an emitter at least for the duration of the coronavirus pandemic. Although they are unlikely to prevent infection, such irradiators can still kill at least some of the viruses and bacteria.

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