Vitamin D supplementation is widely recommended for bone health in the general population, but data on whether it prevents fractures is inconsistent.
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In a secondary study of the Vitamin D and Omega-3 Trial (VITAL), we tested whether vitamin D was a supplement.3 It would result in a lower risk of fracture than placebo. VITAL was a two-factor, randomized controlled trial, which investigated whether or not vitamin D was supplemented.3 (2000 IU per day), n−3 fatty acids (1 g per day), or both prevent cancer and cardiovascular disease in men 50 or older and women 55 or older in the United States. Participants were not recruited on the basis of vitamin D deficiency, low bone mass, or osteoporosis. Accident fractures were reported by participants in annual surveys and adjudicated by review of central medical records. The primary end points were total fractures, non-vertebral fractures, and hip fractures. Proportional hazards models were used to estimate the effect of treatment in intent-to-treat analyses.
Out of 25,871 participants (50.6% women .) [13,085 of 25,871] and 20.2% black [5106 of 25,304]), we confirmed fractures in 1991 in 1551 participants over a median follow-up of 5.3 years. Supplemental Vitamin D3Compared with placebo, it had no 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 adjustment for treatment effect according to baseline characteristics, including age, sex, race, ethnic group, body mass index, or serum 25-hydroxyvitamin D levels. There were no significant between-group differences in adverse events as assessed in the parental experience.
Vitamin D3 Supplementation did not lead to a significantly lower risk of fractures than placebo among generally healthy middle-aged adults 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 No., NCT01704859.)
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