title: Update on the Vitamin D and OmegA-3 trial (VITAL).
abstract: Despite continued appreciation of the potential role of vitamin D and omega-3 fatty acids in the prevention of cancer and cardiovascular disease (CVD), there remain no completed large-scale, randomized trials of these agents for the primary prevention of cancer or CVD in a population that has not been selected on the basis of elevated risk. The VITamin D and OmegA-3 TriaL (VITAL) is a 2×2 factorial randomized, double-blind, placebo-controlled trial of the benefits and risks of vitamin D (vitamin D3 [cholecalciferol], 2000 IU/d) and marine omega-3 fatty acids (Omacor(®) fish oil, a 1 g/d) in the primary prevention of cancer and CVD among 25,875 men and women, aged ≥50 and ≥55 years, respectively. Randomization began in November 2011 and was completed in March 2014. This report will describe the rationale for the trial and currently available randomized trial data, summarize related ongoing large-scale trials, and provide a brief overview of study design, and an update on randomization milestones, racial/ethnic diversity, biorepository activities, in-depth phenotyping of a subcohort, and ancillary studies.
authors: Division of Preventive Medicine, Department of Medicine Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East Boston, MA 02215, United States; Division of Cardiovascular Medicine, Department of Medicine, VA Boston Healthcare System, West Roxbury Campus, 1400 VFW Parkway, West Roxbury, MA 02132, United States. Electronic address: apradhan@partners.org.
authors: Aruna D
authors: AD
authors: Pradhan
authors: Division of Preventive Medicine, Department of Medicine Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue East Boston, MA 02215, United States; Department of Epidemiology, Harvard School of Public Health, 677 Huntington Avenue, Boston, MA 02115, United States.
authors: JoAnn E
authors: JE
authors: Manson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D019587:Dietary Supplements; D004281:Docosahexaenoic Acids / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D015118:Eicosapentaenoic Acid / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000517:prevention & control*; D018579:Patient Selection; D058028:Research Report; D014481:United States; D014807:Vitamin D / Q000008:administration & dosage*
chemical_list: D004338:Drug Combinations; D014807:Vitamin D; D004281:Docosahexaenoic Acids; D015118:Eicosapentaenoic Acid; C405603:Omacor
keywords: Cancer; Cardiovascular disease; Cholecalciferol; Omega-3 fatty acids; Primary prevention; Randomized controlled trial; Vitamin D