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.

Condition	Intervention	Phase
Cancer Cardiovascular Disease	Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Vitamin D and Omega-3 Trial (VITAL)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Vitamin D

Drug Information available for: Cholecalciferol Vitamin D Fish oil Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

cancer and cardiovascular disease [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment:	20000
Study Start Date:	July 2010
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Vitamin D + fish oil	Dietary Supplement: vitamin D3 Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol Drug: omega-3 fatty acids (fish oil) 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]).
Active Comparator: Vitamin D + fish oil placebo	Dietary Supplement: vitamin D3 Vitamin D3 (cholecalciferol), 2000 IU per day. Other Name: cholecalciferol Dietary Supplement: Fish oil placebo Fish oil placebo
Active Comparator: Vitamin D placebo + fish oil	Drug: omega-3 fatty acids (fish oil) 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]). Dietary Supplement: Vitamin D3 placebo Vitamin D placebo
Placebo Comparator: Vitamin D placebo + fish oil placebo	Dietary Supplement: Vitamin D3 placebo Vitamin D placebo Dietary Supplement: Fish oil placebo Fish oil placebo

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Respondents will be eligible for trial participation if they meet these criteria:

are men aged 50 or more or women aged 55 or more;
have no history of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, CABG, or PCI;
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;
have no allergy to fish or soy;
have no other serious illness that would preclude participation;
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;
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;
are not taking fish oil supplements, or, if taking, willing to forego their use during the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169259

Contacts

Contact: Project Manager

1-800-388-3963

vitalstudy@rics.bwh.harvard.edu

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Brigham and Women's Hospital

National Cancer Institute (NCI)

National Heart, Lung, and Blood Institute (NHLBI)

Office of Dietary Supplements (ODS)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:	JoAnn E. Manson, MD, DrPH	Brigham and Women's Hospital
Principal Investigator:	Julie E. Buring, ScD	Brigham and Women's Hospital

More Information

Additional Information:

Welcome to the VITAL study website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	JoAnn E. Manson, MD, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT01169259 History of Changes
Other Study ID Numbers:	2009P-001217
Study First Received:	January 13, 2010
Last Updated:	January 27, 2013
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:

vitamin D3
omega-3 fatty acids
fish oil

cardiovascular disease
cancer
primary prevention

Additional relevant MeSH terms:

Cardiovascular Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins

Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013

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