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Vitamin D and Omega-3 Trial (VITAL) (VITAL)
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Purpose
| 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: Participant, Investigator, Outcomes Assessor Primary Purpose: Prevention |
| Official Title: | Vitamin D and Omega-3 Trial (VITAL) |
- cancer and cardiovascular disease [ Time Frame: five years ]
| Enrollment: | 25871 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 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.
At baseline, 16,954 VITAL participants provided an optional blood sample. Approximately 6,000 of these participants will provide a follow-up blood sample during years 1-4 of the trial.
At baseline and year 2 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| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
To be eligible for the study, respondents had to, at study entry,:
- be men aged 50 or older or women aged 55 or older;
- 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;
- 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;
- 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;
- not be taking fish oil supplements, or, if taking, willing to forego their use during the trial
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01169259
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02215 | |
| 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | May 11, 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 |
ClinicalTrials.gov processed this record on July 14, 2017