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

January 13, 2010
April 4, 2014
July 2010
October 2017   (final data collection date for primary outcome measure)
cancer and cardiovascular disease [ Time Frame: five years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01169259 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vitamin D and Omega-3 Trial (VITAL)
Vitamin D and Omega-3 Trial (VITAL)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cancer
  • Cardiovascular Disease
  • 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]).
  • Dietary Supplement: Vitamin D3 placebo
    Vitamin D placebo
  • Dietary Supplement: Fish oil placebo
    Fish oil placebo
  • Active Comparator: Vitamin D + fish oil
    Interventions:
    • Dietary Supplement: vitamin D3
    • Drug: omega-3 fatty acids (fish oil)
  • Active Comparator: Vitamin D + fish oil placebo
    Interventions:
    • Dietary Supplement: vitamin D3
    • Dietary Supplement: Fish oil placebo
  • Active Comparator: Vitamin D placebo + fish oil
    Interventions:
    • Drug: omega-3 fatty acids (fish oil)
    • Dietary Supplement: Vitamin D3 placebo
  • Placebo Comparator: Vitamin D placebo + fish oil placebo
    Interventions:
    • Dietary Supplement: Vitamin D3 placebo
    • Dietary Supplement: Fish oil placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25875
October 2017
October 2017   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01169259
2009P-001217
Yes
JoAnn E. Manson, MD, Brigham and Women's Hospital
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)
Principal Investigator: JoAnn E. Manson, MD, DrPH Brigham and Women's Hospital
Principal Investigator: Julie E. Buring, ScD Brigham and Women's Hospital
Brigham and Women's Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP