Vitamin D supplements fail to lower risk of fractures in midlife and among elderly: NEJM
USA: Vitamin D supplements are being widely used for bone health in general population but there is an inconsistent data on whether they prevent fractures. Working on the same lines, Meryl S. LeBoff, and colleagues in a new study found that Vitamin D3 supplementation did not significantly reduce the risk of fractures than placebo in generally healthy midlife and older adults.
In an ancillary study of the Vitamin D and Omega-3 Trial (VITAL), the researchers tested whether supplemental vitamin D3 lowers the risk of fractures than placebo in their research published in the New England Journal of Medicine.
VITAL was a two-by-two factorial, randomized, controlled trial that examined whether supplemental vitamin D3 (2000 IU per day), n−3 fatty acids (1 g per day), or both would prevent cardiovascular disease and cancer in men aged 50 years or older and women aged 55 years or older in the US. The recruitment of the particionats was done on the basis of vitamin D deficiency, osteoporosis, or low bone mass. Using annual questionnaires, incident fractures reported by participants was noted and adjudicated by centralized medical-record review.
Incident total, nonvertebral, and hip fractures were the primary end points. The treatment effect in intention-to-treat analyses was estimated using Proportional-hazards models.
Key findings of the study include:
- 1991 incident fractures were confirmed in 1551 participants among 25,871 participants (50.6% women [13,085 of 25,871] and 20.2% Black [5106 of 25,304]) 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), nonvertebral fractures (hazard ratio, 0.97), or hip fractures (hazard ratio, 1.01).
- 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.
The researchers conclude, "Vitamin D3 supplementation did not lead to 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."
Reference:
The study titled, "Supplemental Vitamin D and Incident Fractures in Midlife and Older Adults," was published in the New England Journal of Medicine.
DOI: 10.1056/NEJMoa2202106
