期刊
CONTEMPORARY CLINICAL TRIALS
卷 67, 期 -, 页码 56-67出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2018.02.003
关键词
Vitamin D; Omega-3 fatty acids; Bone mineral density; Body composition; Physical performance; Sex differences
资金
- National Institute of Arthritis Musculoskeletal and Skin Diseases (NIAMS/NIH) [R01AR59775]
- National Cancer Institute [U01 CA138962, R01CA138962]
- National Heart, Lung and Blood Institute
- Office of Dietary Supplements
- National Institute of Neurological Disorders and Stroke
- National Center for Complementary and Integrative Health
- Harvard Catalyst - the Harvard Clinical and Translational Science Center [UL1 TR001102]
- Harvard University
Vitamin D supplements are often used to benefit skeletal health, although data on effects of daily high-dose vitamin D alone on bone density and structure are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a double-blind, randomized, placebo-controlled trial testing effects of high-dose supplemental vitamin D-3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (FAs; 1 g/day) for the primary prevention of cancer and cardiovascular disease. The study has a mean treatment period of 5 years among 25,874 U.S. men >= 50 years and women >= 55 years old from all 50 states. The ancillary study, VITAL: Effects on Bone Structure and Architecture, is testing effects of vitamin D-3 and/or omega-3 FAs on musculoskeletal outcomes and body composition in a subcohort of 771 participants. At in-person visits at the Harvard Catalyst Clinical and Translational Science Center (CTSC), participants completed bone density/architecture, body composition, and physical performance assessments at baseline and two-year follow-up. Baseline characteristics were evenly distributed among treatment groups, suggesting that any uninvestigated confounders will be evenly distributed; sex differences were also analyzed. Future analyses of the two-year follow-up visits will elucidate whether daily high dose, supplemental vitamin D-3 and/or omega-3 FAs improve musculoskeletal outcomes, helping to advance clinical and public health recommendations.
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