Does vitamin D help prevent bone fractures? A new study finds that vitamin D supplements do not protect against bone fractures, even in people with low vitamin D levels or osteoporosis.

Vitamin D Supplements Lack Bone Fracture Prevention Benefits

A study published in The New England Journal of Medicine has found that vitamin D supplements do not prevent bone fractures, even in people with low vitamin D levels or osteoporosis. The study, funded by the National Institutes of Health, involved nearly 26,000 participants aged 50 and older who were assigned to take either 2,000 international units of vitamin D per day or a placebo.

The results contradict the long-held belief that vitamin D supplements can protect bone health by helping the body absorb calcium. The study’s findings add to the growing evidence that vitamin D supplements provide limited health benefits, despite their widespread use.

Questioning the Medical Guidance on Vitamin D

The study’s findings have led some experts to call for a reevaluation of the medical guidance on vitamin D supplements. Dr. Steven R. Cummings, a research scientist at the California Pacific Medical Center Research Institute, and Dr. Clifford Rosen, a senior scientist at the MaineHealth Institute for Research, wrote an editorial accompanying the study, urging healthcare providers to stop screening for vitamin D deficiency and recommending vitamin D supplements.

The experts argue that the widespread belief in the benefits of vitamin D supplements is not supported by the evidence. They point out that the National Academy of Medicine’s expert group previously found little evidence to support the claims that vitamin D improves health, yet they still set arbitrary targets for vitamin D levels and recommended supplementation.

Exceptions to the Vitamin D Supplement Recommendation

The experts do acknowledge that there are certain exceptions where vitamin D supplements may be necessary. People with conditions like celiac disease or Crohn’s disease, as well as those who live in environments with limited sun exposure and do not consume enough vitamin D-fortified foods, may still benefit from vitamin D supplements.

However, the experts argue that such severe vitamin D deficiency is “very hard to do in the general population,” suggesting that the vast majority of people do not need to take vitamin D supplements.

The VITAL Trial and Comprehensive Vitamin D Research

The current study is part of a larger research project called the VITAL trial, which is funded by the National Institutes of Health. The VITAL trial was launched after the National Academy of Medicine’s expert group found that most clinical trials on the health effects of vitamin D were inadequate, prompting the need for more comprehensive research.

The first part of the VITAL trial, previously published, found that vitamin D did not prevent cancer or cardiovascular disease in the study participants. The current findings on bone fractures add to the growing body of evidence that the purported benefits of vitamin D supplements may be overstated.

Implications for Healthcare Providers and the Public

The study’s findings have significant implications for healthcare providers and the public. With millions of Americans taking vitamin D supplements and labs performing more than 10 million vitamin D tests each year, the experts’ call to stop screening for vitamin D deficiency and recommending supplements may lead to a significant shift in medical practices.

The study’s results also raise questions about the widespread belief in the benefits of vitamin D supplements, which have been promoted as a way to improve a wide range of health outcomes. The findings suggest that the medical guidance and public perception of vitamin D supplements may need to be reevaluated.

Ongoing Research and Future Directions

While the current study provides strong evidence that vitamin D supplements do not prevent bone fractures, the researchers acknowledge that there may be other health benefits of vitamin D that warrant further investigation. The VITAL trial is ongoing and may uncover additional insights into the potential roles of vitamin D in health and disease.

As the scientific community continues to explore the complex relationships between vitamin D, calcium, and overall health, the findings from this study serve as a reminder that medical guidance should be based on rigorous, high-quality research rather than long-held assumptions or industry influence.

Vitamin D Supplements Don’t Help Another Condition, Study Finds

Health|Study Finds Another Condition That Vitamin D Pills Do Not Help

https://www.nytimes.com/2022/07/27/health/vitamin-d-bone-fractures.html

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The vitamin pills do not prevent bone fractures in most people or protect against many other diseases, adding to questions about medical guidance many now take for granted.

A study of nearly 26,000 people who were assigned to take vitamin D each day found the vitamin had no effect, even among people who had low vitamin D levels or osteoporosis.Credit…MShieldsPhotos/Alamy

July 27, 2022

The idea made so much sense it was almost unquestioningly accepted: Vitamin D pills can protect bones from fractures. After all, the body needs the vitamin for the gut to absorb calcium, which bones need to grow and stay healthy.

But now, in the first large randomized controlled study in the United States, funded by the federal government, researchers report that vitamin D pills taken with or without calcium have no effect on bone fracture rates. The results, published Thursday in The New England Journal of Medicine, hold for people with osteoporosis and even those whose blood tests deemed them vitamin D deficient.

These results followed other conclusions from the same study that found no support for a long list of purported benefits of vitamin D supplements.

So, for the millions of Americans who take vitamin D supplements and the labs that do more than 10 million vitamin D tests each year, an editorial published along with the paper has some advice: Stop.

“Providers should stop screening for 25-hydroxyvitamin D levels or recommending vitamin D supplements and people should stop taking vitamin D supplements in order to prevent major diseases or extend life,” wrote Dr. Steven R. Cummings, a research scientist at the California Pacific Medical Center Research Institute, and Dr. Clifford Rosen, a senior scientist at the the MaineHealth Institute for Research. Dr. Rosen is an editor at The New England Journal of Medicine.

There are exceptions, they say: People with conditions like celiac or Crohn’s disease need vitamin D supplements, as do those who live in conditions where they are deprived of sunshine and may not eat enough foods that are routinely supplemented with vitamin D, such as cereals and dairy products to help them absorb calcium.

Getting into such a severe vitamin D-deprived state is “very hard to do in the general population,” Dr. Cummings said.

The two scientists know that in making such strong statements they are taking on vitamin sellers, testing labs and advocates who have claimed that taking vitamin D, often in huge amounts, can cure or prevent a wide variety of ailments and even help people live longer.

Doctors often check for vitamin D levels as part of routine blood tests.

The study involved 25,871 participants — men aged 50 and older and women 55 and older — who were assigned to take 2,000 international units of vitamin D each day or a placebo.

The research was part of a comprehensive vitamin D study called VITAL. It was funded by the National Institutes of Health and began after an expert group convened by what is now the National Academy of Medicine, a nonprofit organization, examined the health effects of vitamin D supplements and found little evidence. The expert group’s members were supposed to come up with a minimum daily requirement for the vitamin but found that most clinical trials that had studied the subject were inadequate, making them ask if there was any truth to the claims that vitamin D improved health.

The prevailing opinion at the time was that vitamin D was likely to prevent bone fractures. Researchers thought that as vitamin D levels fell, parathyroid hormone levels would increase at a detriment to bones.

Dr. Rosen said those concerns led him and the other members of the National Academy of Medicine’s expert group to set what he called an “arbitrary value” of 20 nanograms per milliliter of blood as the goal for vitamin D levels and to advise people to get 600 to 800 international units of vitamin D supplements to achieve that goal.

Labs in the United States then arbitrarily set 30 nanograms per milliliter as the cutoff point for normal vitamin D levels, a reading so high that almost everyone in the population would be considered vitamin D deficient.

The presumed relationship between vitamin D and parathyroid levels has not held up in subsequent research, Dr. Rosen said. But uncertainty continued, so the National Institutes of Health funded the VITAL trial to get some solid answers about vitamin D’s relationship to health.

The first part of VITAL, previously published, found that vitamin D did not prevent cancer or cardiovascular disease in trial participants. Nor did it prevent falls, improve cognitive functioning, reduce atrial fibrillation, change body composition, reduce migraine frequency, improve stroke outcomes, protect against macular degeneration or reduce knee pain.

Another large study, in Australia, found that people taking the vitamin did not live longer.

Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women’s Hospital in Harvard Medical School and the leader of the main VITAL trial, said the study was so large it included thousands of people with osteoporosis or with vitamin D levels in a range considered low or “insufficient. ” That allowed the investigators to determine that they also received no benefit for fracture reduction from the supplement.

“That will surprise many,” Dr. Manson said. “But we seem to need only small-to-moderate amounts of the vitamin for bone health. Larger amounts do not confer greater benefits.”

The bone study’s first author and principal investigator, Dr. Meryl S. LeBoff, an osteoporosis expert at Brigham and Women’s Hospital, said she was surprised. She had expected a benefit.

But she cautioned that the study did not address the question of whether people with osteoporosis or low bone mass just short of the condition should be taking vitamin D and calcium, along with osteoporosis medications. Professional guidelines say they should take vitamin D and calcium, and she will continue to adhere to them in her own practice.

Dr. Dolores Shoback, an osteoporosis expert at the University of California, San Francisco, also will continue to advise patients with osteoporosis and low bone mass to take vitamin D and calcium.

It is “a simple intervention and I will continue to prescribe it,” she said.

Others go a bit further.

Dr. Sundeep Khosla, a professor of medicine and physiology at the Mayo Clinic, said that since vitamin D “will do little or no harm and may have benefits,” he would continue to advise his patients with osteoporosis to take it, recommending the 600 to 800 units a day in the National Academy of Medicine report.

“I will still tell my family and friends who don’t have osteoporosis to take a multivitamin a day to make sure they don’t get vitamin D deficient,” he said.

Dr. Khosla follows that advice himself. Many multivitamin tablets now contain 1,000 units of vitamin D, he added.

But Dr. Cummings and Dr. Rosen remain firm, even questioning the very idea of a vitamin D deficiency for healthy people.

“If vitamin D doesn’t help, what is a vitamin D deficiency?” Dr. Cummings asked. “That implies you should take vitamin D.”

And Dr. Rosen, who signed off on the National Academy of Medicine report, has become a vitamin D therapeutic nihilist.

“I don’t believe any more in 600 units,” he said. “I don’t believe you should do anything.”

Gina Kolata writes about science and medicine. She has twice been a Pulitzer Prize finalist and is the author of six books, including “Mercies in Disguise: A Story of Hope, a Family’s Genetic Destiny, and The Science That Saved Them.” @ginakolata • Facebook

A version of this article appears in print on  , Section A, Page 17 of the New York edition with the headline: Vitamin D Supplements Don’t Help Protect Bones From Fractures, a Large Study Finds. Order Reprints | Today’s Paper | Subscribe

Vitamin D and Calcium: A Systematic Review of Health Outcomes (Update)

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Archived: This report is greater than 3 years old. Findings may be used for research purposes, but should not be considered current.

Structured Abstract

Background

In 2009, the Institute of Medicine/Food and Nutrition Board constituted a Dietary Reference Intakes (DRI) committee to undertake a review of the evidence that had emerged (since the 1997 DRI report) on the relationship of vitamin D and calcium, both individually and combined, to a wide range of health outcomes, and potential revision of the DRI values for these nutrients. To support that review, several United States and Canadian Federal Government agencies commissioned a systematic review of the scientific literature for use during the deliberations by the committee. The intent was to support a transparent literature review process and provide a foundation for subsequent reviews of the nutrients. The committee used the resulting literature review in their revision of the DRIs.

In 2013, in preparation for a project the National Institutes of Health Office of Dietary Supplements (NIH/ODS) was undertaking related to evidence-based decisionmaking for vitamin D in primary care, based on the updated DRI report, the ODS and AHRQ requested an update to the 2009 systematic review to incorporate the findings of studies conducted since the 2009 evidence review on the relationship between vitamin D alone or vitamin D plus calcium to selected health outcomes and to report on the methods used to assay vitamin D in the included trials.

Purpose

To systematically summarize the evidence on the relationship between vitamin D alone or in combination with calcium on selected health outcomes included in the earlier review: primarily those related to bone health, cardiovascular health, cancer, immune function, pregnancy, all-cause mortality, and vitamin D status; and to identify the vitamin D assay methods and procedures used for the interventional studies that aimed to assess the effect of vitamin D administration on serum 25(OH)D concentrations, and to stratify key outcomes by methods used to assay serum 25(OH)D concentrations.

Data sources

MEDLINE®; Cochrane Central; Cochrane Database of Systematic Reviews; and the Health Technology Assessments; search limited to English-language articles on humans.

Study selection

Primary interventional or prospective observational studies that reported outcomes of interest in human subjects in relation to vitamin D alone or in combination with calcium, as well as systematic reviews that met the inclusion and exclusion criteria.

Data extraction

A standardized protocol with predefined criteria was used to extract details on study design, interventions, outcomes, and study quality.

Data synthesis

We summarized 154 newly identified primary articles and two new systematic reviews that incorporated more than 93 additional primary articles. Available evidence focused mainly on bone health, cardiovascular diseases, or cancer outcomes. Findings were inconsistent across studies for bone health; breast, colorectal, and prostate cancer; cardiovascular disease and mortality; immune function; and pregnancy-related outcomes. Few studies assessed pancreatic cancer and birth outcomes. One new systematic review of observational studies found that circulating 25(OH)D was generally inversely associated with risk for cardiovascular disease. Methods used to assay serum 25(OH)D in studies reporting on key outcomes diverged widely. The current report also identified one new systematic review published since the original report that addressed whether a dose response relationship exists between dietary and supplemental vitamin D intake and serum 25(OH)D concentrations. The systematic review, based on 76 RCTs, reported widely varying increases in serum concentrations of 25(OH)D for similar doses of vitamin D, with a general increase in serum concentration with dietary intake. The RCTs identified for the current report found increases in serum 25(OH)D with supplementation; however, the findings varied by age group and health status of participants, baseline vitamin D status, dose, duration, and assay used to assess serum 25(OH)D.

Limitations

Studies on vitamin D and calcium were not specifically targeted at life stages (except for pregnant and postmenopausal women) specified for the determination of DRI and were often underpowered for their intended outcomes. Studies vary widely in methodological quality and in the assays used to measure vitamin D status.

Conclusions

In solid agreement with the findings of the original report, the majority of the findings concerning vitamin D, alone or in combination with calcium, on the health outcomes of interest were inconsistent. Associations observed in prospective cohort and nested case-control studies were inconsistent, or when consistent, were rarely supported by the results of randomized controlled trials. Clear dose-response relationships between intakes of vitamin D and health outcomes were rarely observed. Although a large number of new studies (and longer followups to older studies) were identified, particularly for cardiovascular outcomes, all-cause mortality, several types of cancer, and intermediate outcomes for bone health, no firm conclusions can be drawn. Studies identified for the current report suggest a possible U-shaped association between serum 25(OH)D concentrations and both all-cause mortality and hypertension and also suggest that the level of supplemental vitamin D and calcium administered in the Women’s Health Initiative Calcium-Vitamin D Trial are not associated with an increased risk for cardiovascular disease or cancer among postmenopausal women who are not taking additional supplemental vitamin D and calcium. Studies suggest the method used to assay 25(OH)D may influence the outcomes of dose-response assessments. Beyond these observations, it is difficult to make any substantive statements on the basis of the available evidence concerning the association of either serum 25(OH)D concentration, vitamin D supplementation, calcium intake, or the combination of both nutrients, with the various health outcomes because most of the findings were inconsistent.

Citation

Newberry SJ, Chung M, Shekelle PG, Booth MS, Liu JL, Maher AR, Motala A, Cui M, Perry T, Shanman R, Balk EM. Vitamin D and Calcium: A Systematic Review of Health Outcomes (Update). Evidence Report/Technology Assessment No. 217. (Prepared by the Southern California Evidence-based Practice Center under Contract No. 290-2012-00006-I.) AHRQ Publication No. 14-E004-EF. Rockville, MD: Agency for Healthcare Research and Quality. September 2014. DOI: https://doi.org/10.23970/AHRQEPCERTA217.

Complivit Calcium D3 – prevention and complex therapy of osteoporosis

About the drug

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Official name:

BAA Complivit ^® Calcium D ₃

Category:

Preparations containing vitamins, minerals, herbal antioxidants

International nonproprietary name:

Calcium carbonate + Colecalciferol

Presentation:

Chewable tablets with orange flavor, #30, #60, #120

Dispensation:

Available without a prescription

Leaflet 9 0003

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Only two tablets of Complivit® Calcium D ₃ help to fill the body’s daily need for calcium and vitamin D!

Complivit® Calcium D ₃ :

• for strengthening bones
• for healthy teeth
• for strong nails
• for beauty of hair

Approved for use by adults and children from 3 years of age. In the Complivit® Calcium D ₃ line, there are small packages for a trial purchase and large, more convenient and beneficial for a course intake. Complivit® Calcium D ₃ is a replenishment of calcium deficiency at an affordable price!

Calcium is a mineral found in the human body in greater quantities than other ions. On average, the human body contains about 1 kg of calcium, approximately 99% is in the skeleton. This is one of the most important components, sufficient intake of which is necessary for the maintenance of normal human life. However, according to studies, 85% of Russians receive only a third of the recommended daily intake of calcium. ¹

The role of calcium for the body is high, it is involved in the following processes:0059 blood coagulation

vitamin D. Main functions vitamin D:

• increased absorption of calcium. In the absence of vitamin D, absorption of incoming calcium occurs only by 10-15%
• activation of calcium transport from the gastrointestinal tract to the intercellular fluid
• participation in the regulation of muscle tone together with calcium
• prevention of calcium loss during resorption

Vitamin D is necessary for all age groups. And the risk of deficiency increases with age.

Composition

Calcium 500 mg (as carbonate) + 300 IU Vitamin D ₃

Formulations0003

Field of application

Dietary supplement Complivit® Calcium D ₃ is an additional source of calcium and vitamin D.

Complivit ^® Calcium D ₃ forte

900 02 1. Lesnyak O. M. Audit of the state of the problem osteoporosis in Eastern Europe and Central Asia 2010 //Osteoporosis and osteopathy. – 2011. – no. 2. – P. 3-6.

Calcium + Vitamin D3: dosage, use and indications | PharmKnowledge

Obviously, products containing cholecalciferol can be considered the drugs of choice for the treatment and prevention of vitamin D insufficiency and deficiency: they are included in domestic and foreign clinical recommendations. But in what cases is it appropriate to recommend combined preparations of vitamin D and calcium to visitors, and what should they pay attention to?

From effect to indications

As is known, the main function of vitamin D is to regulate calcium-phosphorus metabolism. In the form of active metabolites, it takes part in the process of calcium absorption in the intestine and its excretion by the kidneys. In the presence of sufficient vitamin D, intestinal absorption of calcium is optimal. If the need for the “sunshine vitamin” is not compensated, calcium absorption is reduced. Due to the low level of ionized calcium in the blood, the synthesis of parathyroid hormone is stimulated, which works to increase serum calcium, in particular, stimulates the leaching of calcium and phosphorus from bones. This chain of changes leads to a natural result of vitamin D deficiency – a decrease in calcium levels, changes in bone mineralization and, as a result, the development of rickets and osteoporosis.

Of course, you don’t need to let your clients know about these complexities. Suffice it to say that hypovitaminosis D is associated with a negative calcium balance and a decrease in bone mineralization. To prevent these complications and allow complex preparations of vitamin D and calcium, providing potentiation of the action of each of the components. Their main task and leading indication is the prevention and treatment (as part of complex therapy) of osteoporosis, which, as a rule, develops in old age.

• Colecalciferol and calcium are the drugs of choice in requests for drugs to prevent and treat osteoporosis in women during or after menopause, and to strengthen bones in old age.

Dosage and course of treatment

According to the recommendations of the Russian Association of Endocrinologists, the prophylactic dose of vitamin D at 18–50 years of age is 600–800 IU per day, and at the age of over 50 years, 800–1000 IU per day. The dosage of calcium aimed at preventing bone density can be up to 2000 mg per day. In addition, current guidelines state that a single dose of calcium should not exceed 600 mg for better absorption.

Medicines – sources of vitamin D and calcium have balanced formulas and contain 200 or 400 IU of cholecalciferol and 500 mg of calcium. All of them are taken 1 tablet 1-2 times a day, and the average dosage of the components that come with them does not exceed the recommended daily doses.

• When dispensing drugs of this group to clients, it is appropriate to note that the dosage of drugs is chosen in such a way as to compensate for the needs of the body and prevent excess of vitamin and calcium. Therefore, it is impossible to increase the dose indicated in the instructions on your own – this can lead to an increase in the level of calcium in the blood, which is fraught with disruption of the kidneys and blood vessels.

Along with the dosage, it is important to follow the course of treatment recommended in the instructions. On average, it is from 4 to 6 weeks, but it may vary slightly for different drugs.

• When consulting a client, it should be emphasized that it is not necessary to take colecalciferol and vitamin D3 preparations for a long time without consulting a doctor.

Use during pregnancy, lactation, in childhood

Almost all preparations containing cholecalciferol and vitamin D3 can be used during pregnancy and lactation. However, we must not forget that hypercalcemia during pregnancy can adversely affect the development of the fetus. Therefore, the drugs themselves in this group, and their dosage and course of treatment should be selected by the attending physician.

Childhood is also not a contraindication to the use of a combination of cholecalciferol + calcium. But, again, the doctor should decide on the appointment of these drugs for children and select the dose and duration of therapy.

What else should I warn the customer about?

When dispensing combined preparations of vitamin D and calcium, it is important to take into account that calcium salts reduce the pH of gastric juice, slow down gastric motility and, moreover, easily form complexes with a number of substances, which can interfere with the absorption of drugs. Therefore, it is best to take calcium supplements separately from other medications, on average 2 hours before or 4 to 6 hours after, unless otherwise indicated.

In addition, the most common drug interactions with drugs of the following pharmacological groups should be remembered:

• Antibiotics of the tetracycline group – when taken with calcium preparations, the absorption of antibiotics may decrease. Therefore, tetracycline antibiotics should be taken at least 2 hours before or 4-6 hours after taking calcium supplements.
• Bisphosphonates – against the background of simultaneous administration with cholecalciferol and calcium, the absorption of bisphosphonates decreases. Therefore, the time interval between the use of bisphosphonates and calcium preparations should be at least half an hour, and it is better to take them at different times of the day.

NB! Bisphosphonates are first-line drugs for the treatment of osteoporosis and may be part of a complex regimen along with vitamin D and calcium supplements.

• Cardiac glycosides and calcium channel blockers – when taken together with calcium supplements and / or vitamin D, it is recommended to control the level of calcium in the blood to avoid the development of hypercalcemia. The latter increases the risk of fatal arrhythmias in patients receiving digoxin and reduces the effectiveness of calcium channel blockers.
• Thiazide diuretics – reduce calcium excretion, which is associated with an increased risk of hypercalcemia. For patients receiving these drugs, it is important to regularly monitor serum calcium levels.

We have listed only the most common drug interactions, the full list is much longer. And in order to prevent them, it is important to strongly recommend that the client take any medications separately from calcium and vitamin D preparations. And to make it easier for you to navigate in a fairly large assortment, we have prepared a table for download, in which we have collected currently registered drugs containing cholecalciferol and calcium with dosages of active ingredients and indications.