|Phase III||Prevention||Active||60 and over||NCI, Other||2009P-001217|
The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses.
Further Study Information
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 U.S. mail.
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.
Respondents will be eligible for trial participation if they meet these criteria:
1. are men aged 50 or more or women aged 55 or more;
2. have no history of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, CABG, or PCI;
3. have none of the following safety exclusions: history of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis;
4. have no allergy to fish or soy;
5. have no other serious illness that would preclude participation;
6. are consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
7. are consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
8. are not taking fish oil supplements, or, if taking, willing to forego their use during the trial
Trial Lead Organizations/Sponsors
Dana-Farber/Brigham and Women's Cancer CenterNational Cancer Institute
National Heart, Lung, and Blood Institute
Office of Dietary Supplements (ODS)
National Institute of Neurological Disorders and Stroke
National Center for Complementary and Alternative Medicine
|JoAnn Manson||Principal Investigator|
|Julie E. Buring||Principal Investigator|
|Project Manager||Ph: 1-800-388-3963|
|Dana-Farber/Brigham and Women's Cancer Center|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01169259
ClinicalTrials.gov processed this data on December 15, 2013
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