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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01169259
First Posted: July 26, 2010
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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 Integrative Health (NCCIH)
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital
  Purpose
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 (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
Intervention Model: Factorial Assignment
Masking: Triple (Participant, 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 JoAnn E. Manson, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Total cancer [ Time Frame: 5 years ]
  • Major CVD events [ Time Frame: 5 years ]
    Major CVD events = a composite endpoint of myocardial infarction, stroke, and CVD mortality


Secondary Outcome Measures:
  • Colorectal cancer [ Time Frame: 5 years ]
  • Breast cancer (in women) [ Time Frame: 5 years ]
  • Prostate cancer (in men) [ Time Frame: 5 years ]
  • Total cancer mortality [ Time Frame: 5 years ]
  • Expanded CVD events [ Time Frame: 5 years ]
    Expanded CVD events = a composite endpoint of myocardial infarction, stroke, CVD mortality, and coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention)

  • CVD mortality [ Time Frame: 5 years ]
  • Myocardial infarction [ Time Frame: 5 years ]
  • Stroke [ Time Frame: 5 years ]
  • Total mortality [ Time Frame: 5 years ]

Other Outcome Measures:
  • Colorectal adenoma [ Time Frame: 5 years ]

Enrollment: 25871
Study Start Date: July 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (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 (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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169259


Locations
United States, Massachusetts
Brigham and Women's Hospital
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 Integrative Health (NCCIH)
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:
Publications:
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
First Submitted: January 13, 2010
First Posted: July 26, 2010
Last Update Posted: October 2, 2017
Last Verified: September 2017

Keywords provided by JoAnn E. Manson, MD, Brigham and Women's Hospital:
vitamin D3
omega-3 fatty acids
fish oil
cardiovascular disease
cancer
primary prevention

Additional relevant MeSH terms:
Cardiovascular Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents