Vitamin D and Omega-3 Trial (VITAL) "VITAL"

Active, not recruiting

Phase 3 Results N/A

Trial Description

The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing 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 (OmacorĀ® 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.

Detailed Description

The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing 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 will test 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 will also explore (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 of vitamin D and EPA+DHA, race/ethnicity (for vitamin D), and body mass index (for vitamin D), as well as age, sex, sunlight exposure, calcium and phosphorus intakes, 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 take two pills each day -- one softgel that contains either vitamin D or vitamin D placebo and one capsule that contains either omega-3 or omega-3 placebo. Participants receive their study pills in convenient calendar packages via U.S. mail.
Participants 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.
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 1-4 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 have a clinical exam, including measurement of height, weight, other anthropometrics, blood pressure, and physical performance. They also provide fasting blood and urine samples, and undergo 2-hour oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms, bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.

Conditions

Interventions

  • Omega-3 fatty acids Drug
    Other Names: Omacor (ethyl esters of omega-3 polyunsaturated fatty acids)
  • Placebo Drug
    Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
  • Vitamin D3 Dietary Supplement
    Other Names: cholecalciferol
    Intervention Desc: Vitamin D3 (cholecalciferol), 2000 IU per day.
    ARM 1: Kind: Experimental
    Label: Vitamin D + fish oil
    ARM 2: Kind: Experimental
    Label: Vitamin D + fish oil placebo
  • Omega-3 fatty acids (fish oil) Drug
    Intervention Desc: Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
    ARM 1: Kind: Experimental
    Label: Vitamin D + fish oil
    ARM 2: Kind: Experimental
    Label: Vitamin D placebo + fish oil
  • Vitamin D3 placebo Dietary Supplement
    Intervention Desc: Vitamin D placebo
    ARM 1: Kind: Experimental
    Label: Vitamin D placebo + fish oil
    ARM 2: Kind: Experimental
    Label: Vitamin D placebo + fish oil placebo
  • Fish oil placebo Dietary Supplement
    Intervention Desc: Fish oil placebo
    ARM 1: Kind: Experimental
    Label: Vitamin D + fish oil placebo
    ARM 2: Kind: Experimental
    Label: Vitamin D placebo + fish oil placebo

Trial Design

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

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary cancer and cardiovascular disease
Primary Total cancer 5 years
Primary Major CVD events 5 years
Secondary Colorectal cancer 5 years
Secondary Breast cancer (in women) 5 years
Secondary Prostate cancer (in men) 5 years
Secondary Total cancer mortality 5 years
Secondary Expanded CVD events 5 years
Secondary CVD mortality 5 years
Secondary Myocardial infarction 5 years
Secondary Stroke 5 years
Secondary Total mortality 5 years

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