Vitamin D and Omega-3 Fatty Acids (VITAL Trial): Effects on Fractures
The VITAL: Effects on Fracture Study is an ancillary study of the parent VITAL trial
(VITamin D and OmegA-3 TriaL). The study will require the adjudication of all self-reported
incident fracture events among 10,000 men and 10,000 women. Findings from this ancillary
study will inform clinical practice on the role(s) of vitamin D and/or omega-3 fatty acid
supplements in fracture prevention. Because of the very high prevalence of low vitamin D
levels and fractures in older adults, this trial will enable us to prove or disprove whether
high-dose vitamin D and/or fish oil supplementation is effective in the primary prevention
of age-related osteoporotic fractures in the U.S. These nutritional supplements may offer
low-cost preventative interventions and reduce the burden of osteoporotic fractures with the
potential for substantial individual and public health benefits.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Incident total fractures
To determine whether vitamin D and/or fish oil supplementation will reduce incident total fractures according to annual questionnaires, medical record review, and fracture adjudication.
Meryl S LeBoff, M.D.
Brigham and Women's Hospital
United States: Institutional Review Board
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