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

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.
 
ClinicalTrials.gov Identifier: NCT01169259
Recruitment Status : Active, not recruiting
First Posted : July 26, 2010
Results First Posted : January 6, 2020
Last Update Posted : July 31, 2020
Sponsor:
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)
Pharmavite LLC
Pronova BioPharma
BASF
Information provided by (Responsible Party):
JoAnn E. Manson, MD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE January 13, 2010
First Posted Date  ICMJE July 26, 2010
Results First Submitted Date  ICMJE November 12, 2019
Results First Posted Date  ICMJE January 6, 2020
Last Update Posted Date July 31, 2020
Study Start Date  ICMJE July 2010
Actual Primary Completion Date November 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2020)
  • Number of Participants With Invasive Cancer of Any Type [ Time Frame: 5 years ]
    Invasive cancer of any type
  • Number of Participants With a Major Cardiovascular Event [ Time Frame: 5 years ]
    Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes
Original Primary Outcome Measures  ICMJE
 (submitted: July 22, 2010)
cancer and cardiovascular disease [ Time Frame: five years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2020)
  • Number of Participants Who Died From Invasive Cancer of Any Type [ Time Frame: 5 years ]
    Death from invasive cancer of any type
  • Number of Female Participants With Breast Cancer [ Time Frame: 5 years ]
    Breast cancer (in women)
  • Number of Male Participants With Prostate Cancer [ Time Frame: 5 years ]
    Prostate cancer (in men)
  • Number of Participants With Colorectal Cancer [ Time Frame: 5 years ]
    Colorectal cancer
  • Number of Participants With Cardiovascular Event in Expanded Composite Cardiovascular Endpoint [ Time Frame: 5 years ]
    Expanded composite cardiovascular endpoint = a composite endpoint of myocardial infarction, stroke, death from cardiovascular causes, and coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention)
  • Number of Participants With Myocardial Infarction [ Time Frame: 5 years ]
    Myocardial infarction
  • Number of Participants With Stroke [ Time Frame: 5 years ]
    Stroke
  • Number of Participants Who Died From Cardiovascular Causes [ Time Frame: 5 years ]
    Death from cardiovascular causes
  • Number of Participants Who Died From Any Cause [ Time Frame: 5 years ]
    Death from any cause
  • Number of Participants With Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up [ Time Frame: 5 years, excluding first 2 years of follow-up ]
    Invasive cancer of any type, excluding first 2 years of follow-up
  • Number of Participants With a Major Cardiovascular Event, Excluding First 2 Years of Follow-up [ Time Frame: 5 years, excluding first 2 years of follow-up ]
    Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes; excluding first 2 years of follow-up
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: July 15, 2020)
  • Number of Participants Who Died From Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up [ Time Frame: 5 years, excluding first 2 years of follow-up ]
    Death from invasive cancer of any type, excluding first 2 years of follow-up
  • Number of Participants Who Died From Any Cause, Excluding First 2 Years of Follow-up [ Time Frame: 5 years, excluding first 2 years of follow-up ]
    Death from any cause, excluding first 2 years of follow-up
  • Number of Participants With Percutaneous Coronary Intervention [ Time Frame: 5 years ]
    Percutaneous coronary intervention
  • Number of Participants With Coronary-artery Bypass Grafting [ Time Frame: 5 years ]
    Coronary-artery bypass grafting
  • Number of Participants With Total Coronary Heart Disease [ Time Frame: 5 years ]
    Total coronary heart disease = a composite of myocardial infarction, coronary revascularization (percutaneous coronary intervention or coronary-artery bypass grafting), and death from coronary heart disease
  • Number of Participants With Ischemic Stroke [ Time Frame: 5 years ]
    Ischemic stroke
  • Number of Participants With Hemorrhagic Stroke [ Time Frame: 5 years ]
    Hemorrhagic stroke
  • Number of Participants Who Died From Myocardial Infarction [ Time Frame: 5 years ]
    Death from myocardial infarction
  • Number of Participants Who Died From Coronary Heart Disease [ Time Frame: 5 years ]
    Death from coronary heart disease
  • Number of Participants Who Died From Stroke [ Time Frame: 5 years ]
    Death from stroke
  • Number of Participants With Myocardial Infarction, Excluding First 2 Years of Follow-up [ Time Frame: 5 years, excluding first 2 years of follow-up ]
    Myocardial infarction, excluding first 2 years of follow-up
  • Number of Participants With Conventional Colorectal Adenoma [ Time Frame: 5 years ]
    tubular, tubulovillous, villous adenoma; adenoma w/high-grade dysplasia
  • Number of Participants With Serrated Colorectal Polyps [ Time Frame: 5 years ]
    hyperplastic polyp, traditional serrated adenoma, sessile serrated polyp
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D and Omega-3 Trial (VITAL)
Official Title  ICMJE Vitamin D and Omega-3 Trial (VITAL)
Brief Summary The VITamin D and OmegA-3 TriaL (VITAL) is a 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. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.
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 (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 tested 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 also explored (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 or intake of vitamin D and EPA+DHA, race/ethnicity, and body mass index (for vitamin D), as well as age, sex, sunlight exposure, calcium intake, 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 took two pills each day -- one softgel that contained either vitamin D or vitamin D placebo and one capsule that contained either omega-3 or omega-3 placebo. Participants received their study pills in convenient calendar packages via U.S. mail.

Participants 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. We request consent for medical record review to confirm endpoints. 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 1-5 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 had a clinical exam, including measurement of height, weight, other anthropometrics, blood pressure, and physical performance. They also provided fasting blood and urine samples, and underwent 2-hour oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms, bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.

VITAL is supported by funding from the National Cancer Institute, National Heart, Lung and Blood Institute, Office of Dietary Supplements, National Institute of Neurological Disorders and Stroke, and the National Center for Complementary and Integrative Health. Pharmavite LLC of Northridge, California (vitamin D) and Pronova BioPharma (BASF) of Norway (Omacor® fish oil) donated the study agents, matching placebos, and packaging in the form of calendar packs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cancer
  • Cardiovascular Disease
Intervention  ICMJE
  • Dietary Supplement: vitamin D3
    Vitamin D3 (cholecalciferol), 2000 IU per day.
    Other Name: cholecalciferol
  • Drug: omega-3 fatty acids (fish oil)
    Omacor, one 1-gram 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 11, 2017)
25871
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2010)
20000
Estimated Study Completion Date  ICMJE November 2020
Actual Primary Completion Date November 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, coronary-artery bypass grafting, or percutaneous coronary intervention;
  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 granulomatosis with polyangiitis (Wegener's);
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01169259
Other Study ID Numbers  ICMJE 2009P-001217
U01CA138962 ( U.S. NIH Grant/Contract )
R01CA138962 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Researchers who are interested in collaborating on research that uses VITAL data should visit the "For VITAL Investigators" section of the VITAL website, www.vitalstudy.org.
URL: http://www.vitalstudy.org/Investigators.html
Responsible Party JoAnn E. Manson, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE
  • 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)
  • Pharmavite LLC
  • Pronova BioPharma
  • BASF
Investigators  ICMJE
Principal Investigator: JoAnn E. Manson, MD, DrPH Brigham and Women's Hospital
Principal Investigator: Julie E. Buring, ScD Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date July 2020

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