take Vitamin D Supplements did not significantly reduce the risk of fractures in middle-aged and elderly adults compared to placebo, according to the results of a supplemental study of the Vitamin D and Omega 3 study (VITAL).
Dr. Merrill Lebov
The data showed that daily supplementation with 2000 IU of vitamin D without co-administration had no significant effect on non-spinal fractures (hazard ratio). [HR]0.97; P = .50), hip fracture (HR, 1.01; P = .96), or total fracture (HR, 0.98; P = .70), compared to taking a placebo, osteoporosisVitamin D Deficiency, or Low Bone Mass, reports Merrill S. Lebov, a medical professor at Harvard Medical School and head of the calcium and bone department at Brigham and Women’s Hospital in Boston, Massachusetts. ..
The survey results are Published online July 27 The New England Journal of Medicine.
Previous randomized controlled trials showed conflicting results. Some have shown that vitamin D supplementation has some benefits, while others have shown that it has no effect or even harm in terms of the risk of fractures.
“Because of the inconsistent data at the time, we tested this hypothesis to better science and understanding the effects of vitamin D on bone. Previous studies have shown the effect of vitamin D supplementation on bone density. I didn’t. A subcohort of the VITAL exam. “ Medscape Medical News..
“According to PQCT, we previously reported that about 2000 units of vitamin D per day did not increase bone density and did not affect bone structure. [peripheral quantitative CT].. This indicates that bone density may not affect fractures because it is a surrogate marker for fractures, “she added.
These results should dispel the idea that vitamin D alone can significantly reduce fracture rates in the general population, Stephen R. Cummings, UC San Francisco, and Clifford, Main Medical Center Institute. Dr. Rosen said. Scarborough, Ancillary editorial..
“Adding these findings to previous reports from VITAL and other trials showing that they are ineffective in preventing many conditions may result in providers screening for 25-hydroxyvitamin D levels or recommending vitamin D supplements. It suggests that people should stop taking vitamin D supplements to prevent them, prolonging major illnesses and longevity, “the editors write.
The researchers evaluated 25,871 participants from all 50 states during a median follow-up of 5.3 years. Participants were randomly assigned in a 1: 1 ratio to receive placebo or vitamin D.
The average age of the participants was 67.1 years. 50.6% of the study cohort was female and 20.2% of the cohort was black. Participants did not suffer from low bone mass, vitamin D deficiency, or osteoporosis.
Participants agreed not to supplement their dietary intake with more than 1200 mg of calcium and less than 800 IU of vitamin D daily.
Participants completed a detailed study to assess baseline prescription drug use, demographic factors, medical history, and supplement consumption. Fish oil, Calcium, and Vitamin D, during the break-in phase. The annual survey assesses side effects, adherence to research protocols, falls, fractures, physical activity, osteoporosis and related risk factors, the development of major illnesses, and the use of non-test prescription medications and supplements such as vitamin D and calcium. Used for
Researchers used a centralized medical record review to determine incident fracture data. They used the proportional hazards model to estimate the therapeutic effect in the treatment intent analysis.
In particular, the results were similar for the placebo and vitamin D groups with respect to the incident. Kidney stone And hypercalcemia.
The effectiveness of vitamin D supplementation was not altered by baseline parameters such as race or ethnicity, gender, obesity index, age, or blood 25-hydroxyvitamin D levels.
Cummings and Rosen, along with other VITAL study data, found that subgroups (including levels below 20 ng / mL) classified based on baseline 25-hydroxyvitamin D levels were vitamin supplemented. It points out that it indicates that it is not benefiting.
“There is no reason to measure 25-hydroxyvitamin D in the general population or treat it to target serum levels. 25-hydroxyvitamin D levels are in some patients with potentially severe causes. It can be a useful diagnostic test for people. It’s lacking, “the editors point out.
Rosen and Cummings need to reassess the use of the terms “vitamin D deficiency” and “vitamin D” deficiency “, except in certain patients, such as individuals living in nursing homes with limited exposure to sunlight. ..
The limits of this study include assessing single doses of vitamin D supplements and lack of coordination for diversity, exploratory, parental trials, or secondary endpoints, the researchers said. I am.
Due to ethical and feasibility concerns regarding these patients, the number of participants with vitamin D deficiency was limited.Data are for older and institutionalized individuals, or Osteomalacia Or osteoporosis, researchers write.
Expert commentary
“Interpretation of this [study] For me, Vitamin D is not suitable for everyone, “said Dr. Baha Alafa, a medical professor at Case Western Reserve University and director of endocrinology at a university hospital in Cleveland, Ohio.
“This is not the last word. We recommend that you do not throw vitamin D to everyone. In particular, use markers of bone formation as a better measure to determine if you need vitamin D. .. Parathyroid hormone“Arafat said in a telephone interview.
Arafat pointed out that these data do not mean that clinicians should stop thinking about vitamin D altogether. “I think it’s the wrong message to read. Read the article and you’ll see that some people need vitamin D. Those who are deficient need vitamin D. Excess or extreme vitamin D No doubt. Deficiency is something else, specifically bone softening, weak bones, [and] Due to its poor mineralization, it is not completely out of the forest at this time. “
Auxiliary studies of the VITAL trial were sponsored by the National Institute of Arthritis and Musculoskeletal and Skin Diseases.Pharmavite donated vitamin D 3 The supplement used in the test. LeBoff reports that she holds a stake in Amgen. Cummings reports personal fees and non-financial support from Amgen other than her submitted work. Rosen is Deputy Editor-in-Chief of The New England Journal of Medicine. Day of Arafat No relevant financial relationships have been reported.
N Engl J Med. Published online on July 27, 2022. Overview, editorial
Ashley Lyles is an award-winning medical journalist. She is a graduate of New York University’s Science, Health and Environmental Reporting Program. Her work has been published in publications such as The New York Times Daily 360, PBS NewsHour, The Huffington Post, Undark, The Root, Psychology Today, Insider, and Tonic (Health by Vice).
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