期刊
CONTEMPORARY CLINICAL TRIALS
卷 47, 期 -, 页码 235-243出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2015.12.022
关键词
Cancer; Cardiovascular disease; Omega-3 fatty acids; Primary prevention; Randomized clinical trial; Vitamin D
资金
- National Cancer Institute
- National Heart, Lung and Blood Institute
- Office of Dietary Supplements
- National Institute of Neurological Disorders and Stroke
- National Center for Complementary and Integrative Health
- National Institute of Diabetes and Digestive and Kidney Diseases
- National Institute on Aging
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- National Institute of Mental Health
- National Eye Institute
- [U01 CA138962]
- [R01 CA138962]
Evidence for a role of supplemental vitamin D and marine omega-3 fatty acids in preventing cancer and cardiovascular disease (CVD) remains inconclusive and insufficient to inform nutritional recommendations for primary prevention. The VITamin D and Omega-A 3 TriaL (VITAL) is an ongoing nationwide, randomized, double-blind, placebo-controlled clinical trial designed to fill this knowledge gap. The study population consists of 25,874 U.S. adults without cancer or CVD at baseline, who were selected only on age (men aged >= 50 and women aged >= 55), with an oversampling of African Americans (n = 5,107). In a 2 x 2 factorial design, participants were randomized to one of four supplement groups: [1] active vitamin D3 (cholecalciferol; 2000 IU/d) and active marine omega-3 fatty acids (Omacor fish oil, eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA], 1 g/d); [2] active vitamin D and omega-3 placebo; [3] vitamin D placebo and active marine omega-3 fatty acids; or [4] vitamin D placebo and omega-3 placebo. The mean length of the randomized treatment period will be 5 years. The randomization was successful, as evidenced by similar distributions of baseline demographic, health, and behavioral characteristics across treatment groups. The similar distribution of known potential confounders across treatment groups strongly suggests that unmeasured or unknown potential confounders are also equally distributed. VITAL is expected to provide important information on the benefit-risk balance of vitamin D and omega-3 fatty acid supplementation when taken for the primary prevention of cancer and CVD. (C) 2015 Elsevier Inc. All rights reserved.
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