4.8 Article

Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults

Journal

NEW ENGLAND JOURNAL OF MEDICINE
Volume 387, Issue 4, Pages 299-309

Publisher

MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa2202106

Keywords

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Funding

  1. National Institute of Arthritis and Musculoskeletal and Skin Diseases [R01 AR060574, R01 AR070854, R01 AR059775]
  2. National Cancer Institute [U01 CA138962, R01 CA138962, R01AT011729]
  3. National Heart, Lung, and Blood Institute
  4. Office of Dietary Supplements
  5. National Institute of Neurological Disorders and Stroke
  6. National Center for Complementary and Integrative Health

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The study found that supplementing with vitamin D3 does not significantly reduce the risk of fractures in generally healthy middle-aged and older adults, regardless of total, nonvertebral, or hip fractures.
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 D-3 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 D-3 (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 D-3, 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 D-3 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.)

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