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Study Finds Another Condition That Vitamin D Pills Do Not Help - NYT July 2022


New York Times reporting on NEJM study

NYT

  • "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."
NO Calcium was used in the trial - yet NYT said otherwise
Half of participants had sufficient Vitamin D
Many were likely taking 800 IU daily (intervention group also took 2,000 IU)

NEJM sub-study of VITAL - July 2022

Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults
N Engl J Med 2022; 387:299-309 July 28, 2022 DOI: 10.1056/NEJMoa2202106
Meryl S. LeBoff, M.D., Sharon H. Chou, M.D., Kristin A. Ratliff, B.A., Nancy R. Cook, Sc.D., Bharti Khurana, M.D., Eunjung Kim, M.S., Peggy M. Cawthon, Ph.D., M.P.H., Douglas C. Bauer, M.D., Dennis Black, Ph.D., J. Chris Gallagher, M.D., I-Min Lee, M.B., B.S., Sc.D., Julie E. Buring, Sc.D., et al.

BACKGROUND
Vitamin D supplements are widely recommended for bone health in the general population, but data on whether they prevent fractures have been inconsistent.

METHODS
In an ancillary study of the Vitamin D and Omega-3 Trial (VITAL), we tested whether supplemental vitamin D3 would result in a lower risk of fractures than placebo. VITAL was a two-by-two factorial, randomized, controlled trial that investigated whether supplemental vitamin D3 (2000 IU per day), n−3 fatty acids (1 g per day), or both would prevent cancer and cardiovascular disease in men 50 years of age or older and women 55 years of age or older in the United States. Participants were not recruited on the basis of vitamin D deficiency, low bone mass, or osteoporosis. Incident fractures were reported by participants on annual questionnaires and adjudicated by centralized medical-record review. The primary end points were incident total, nonvertebral, and hip fractures. Proportional-hazards models were used to estimate the treatment effect in intention-to-treat analyses.

RESULTS
Among 25,871 participants (50.6% women [13,085 of 25,871] and 20.2% Black [5106 of 25,304]), we confirmed 1991 incident fractures in 1551 participants over a median follow-up of 5.3 years. Supplemental vitamin D3, as compared with placebo, did not have a significant effect on total fractures (which occurred in 769 of 12,927 participants in the vitamin D group and in 782 of 12,944 participants in the placebo group; hazard ratio, 0.98; 95% confidence interval [CI], 0.89 to 1.08; P=0.70), nonvertebral fractures (hazard ratio, 0.97; 95% CI, 0.87 to 1.07; P=0.50), or hip fractures (hazard ratio, 1.01; 95% CI, 0.70 to 1.47; P=0.96). There was no modification of the treatment effect according to baseline characteristics, including age, sex, race or ethnic group, body-mass index, or serum 25-hydroxyvitamin D levels. There were no substantial between-group differences in adverse events as assessed in the parent trial.

CONCLUSIONS
Vitamin D3 supplementation did not result in a significantly lower risk of fractures than placebo among generally healthy midlife and older adults who were not selected for vitamin D deficiency, low bone mass, or osteoporosis. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases; VITAL ClinicalTrials.gov number, NCT01704859. opens in new tab.)


VITAL did not use Calcium nor exercise needed to build bones


NEJM Editorial in the same issue

  • “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,”
  • "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.”

VitaminDWiki - Falls and Fractures category contains

Falls

Fracture

Click here for details


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