Vitamin D and Omega-3 Trial (VITAL)
The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial of vitamin D (in the
form of vitamin D3 [cholecalciferol]) and marine omega-3 fatty acid (eicosapentaenoic acid
[EPA] + docosahexaenoic acid [DHA]) supplements in the primary prevention of cancer and
cardiovascular disease. Existing data from laboratory studies, epidemiologic research, small
primary prevention trials, and/or large secondary prevention trials strongly suggest that
these nutritional agents may reduce risk for cancer or cardiovascular disease, but large
primary prevention trials with adequate dosing in general populations are lacking.
Eligible participants will be assigned by chance (like a coin toss) to one of four groups:
(1) daily vitamin D3 and omega-3; (2) daily vitamin D3 and omega-3 placebo; (3) daily
vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo.
Participants have an equal chance of being assigned to any of these four groups and a 3 out
of 4 chance of getting at least one active agent.
Participants in all groups will take two pills each day -- one softgel that contains either
vitamin D3 or vitamin D placebo and one capsule that contains either omega-3 or omega-3
placebo. Participants will receive their study pills in convenient calendar packages via
Participants will also fill out a short (15-20 minute) questionnaire each year. The
questionnaire asks about health; lifestyle habits such as physical exercise, diet, and
smoking; use of medications and dietary supplements; family history of illness, and new
medical diagnoses. Occasionally, participants may receive a phone call from study staff to
collect information or to clarify responses on the questionnaire.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
cancer and cardiovascular disease
JoAnn E. Manson, MD, DrPH
Brigham and Women's Hospital
United States: Institutional Review Board
|Brigham and Women's Hospital||Boston, Massachusetts 02115|