Vitamin D and Omega-3 Trial (VITAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01169259
First received: January 13, 2010
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

The VITamin D and OmegA-3 TriaL (VITAL) is an ongoing randomized clinical trial in 25,875 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:


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 ]

Enrollment: 25875
Study Start Date: July 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (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 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. 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 were 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 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 D3 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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, 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. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
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:
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: April 4, 2014
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 August 01, 2014