Vitamin D and Omega-3 Trial (VITAL)
The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 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. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.
Inclusion Criteria
- To be eligible for the study, respondents had to, at study entry,: 1. be men aged 50 or older or women aged 55 or older; 2. have no history of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, coronary-artery bypass grafting, or percutaneous coronary intervention; 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 granulomatosis with polyangiitis (Wegener's); 4. have no allergy to fish or soy; 5. have no other serious illness that would preclude participation; 6. be 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. be 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. not be taking fish oil supplements, or, if taking, willing to forego their use during the trial
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01169259.
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 (CVD). 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 CVD, but
large primary prevention trials with adequate dosing in general populations are lacking.
VITAL tested the independent effects of vitamin D and omega-3 fatty acid supplementation
on risk for developing cancer and CVD (primary, secondary, and other outcomes are
specified in the Outcome Measures section). VITAL also explored (a) whether vitamin D and
omega-3 fatty acid supplements exhibit synergistic or additive effects on cancer and CVD
risk and (b) whether the effect of each supplement on cancer and CVD risk varies by
baseline blood levels or intake of vitamin D and EPA+DHA, race/ethnicity, and body mass
index (for vitamin D), as well as age, sex, sunlight exposure, calcium intake, and
baseline risk factors for cancer and CVD.
Eligible participants were assigned by chance (like a coin toss) to one of four groups:
(1) daily vitamin D and omega-3; (2) daily vitamin D and omega-3 placebo; (3) daily
vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo.
Participants had 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 took two pills each day -- one softgel that contained either
vitamin D or vitamin D placebo and one capsule that contained either omega-3 or omega-3
placebo. Participants received their study pills in convenient calendar packages via U.S.
mail.
Participants 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. We request consent for medical record review to confirm endpoints.
Occasionally, participants may receive a phone call from study staff to collect
information or to clarify responses on the questionnaire.
At baseline, 16,954 VITAL participants provided an optional blood sample. Approximately
6,000 of these participants provided a follow-up blood sample during years 1-5 of the
trial.
At baseline, year 2, and year 4 of the trial, a subcohort of 1,054 VITAL participants
living within driving distance of Boston, Massachusetts received detailed in-clinic
health assessments at the Clinical and Translational Science Center (CTSC) of Brigham and
Women's Hospital. During CTSC visits, participants had a clinical exam, including
measurement of height, weight, other anthropometrics, blood pressure, and physical
performance. They also provided fasting blood and urine samples, and underwent 2-hour
oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms,
bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.
VITAL is supported by funding from the National Cancer Institute, National Heart, Lung
and Blood Institute, Office of Dietary Supplements, National Institute of Neurological
Disorders and Stroke, and the National Center for Complementary and Integrative Health.
Pharmavite LLC of Northridge, California (vitamin D) and Pronova BioPharma (BASF) of
Norway (Omacor® fish oil) donated the study agents, matching placebos, and packaging in
the form of calendar packs.
Trial PhasePhase III
Trial Typeprevention
Lead OrganizationBrigham and Women's Hospital
- Primary ID2009P-001217
- Secondary IDsNCI-2020-03468, R01CA138962, U01CA138962
- ClinicalTrials.gov IDNCT01169259