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Vitamin D and Omega-3 Trial (VITAL)

Phase 3
50 Years
Open (Enrolling)
Cancer, Cardiovascular Disease

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Trial Information

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
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.

Inclusion Criteria

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

cancer and cardiovascular disease

Outcome Time Frame:

five years

Safety Issue:


Principal Investigator

JoAnn E. Manson, MD, DrPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital


United States: Institutional Review Board

Study ID:




Start Date:

July 2010

Completion Date:

June 2016

Related Keywords:

  • Cancer
  • Cardiovascular Disease
  • vitamin D3
  • omega-3 fatty acids
  • fish oil
  • cardiovascular disease
  • cancer
  • primary prevention
  • Cardiovascular Diseases



Brigham and Women's Hospital Boston, Massachusetts  02115