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Omega-3 Fatty Acid

Vitamin D + Omega-3 for Cancer and Cardiovascular Disease (VITAL Trial)

Phase 3
Waitlist Available
Led By Julie E. Buring, ScD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must 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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years, excluding first 2 years of follow-up
Awards & highlights
Pivotal Trial

Summary

This trial is investigating whether taking daily supplements of vitamin D3 or omega-3 fatty acids reduces the risk of developing cancer, heart disease, and stroke.

Who is the study for?
The VITAL study is for U.S. adults without past heart disease, stroke, or cancer (except skin cancer). Men must be over 50 and women over 55. Participants shouldn't take more than small doses of vitamin D or calcium supplements, no fish oil supplements, and have no severe illnesses like kidney failure or liver disease.
What is being tested?
This trial tests if daily vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can prevent cancer, heart disease, and stroke in healthy individuals. It's a randomized study where participants unknowingly get either the real supplement or a placebo.
What are the potential side effects?
Potential side effects may include digestive issues from fish oil like burping or stomach discomfort and high calcium levels from too much vitamin D which could cause fatigue or kidney problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had cancer (except skin cancer), heart attack, stroke, or major heart procedures.
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I don't have severe kidney, liver issues, abnormal calcium levels, or certain inflammatory diseases.
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I am a man aged 50 or older, or a woman aged 55 or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years, excluding first 2 years of follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years, excluding first 2 years of follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Invasive Cancer of Any Type
Number of Participants With a Major Cardiovascular Event
Secondary study objectives
Number of Female Participants With Breast Cancer
Number of Male Participants With Prostate Cancer
Number of Participants Who Died From Any Cause
+8 more
Other study objectives
Number of Participants Who Died From Any Cause, Excluding First 2 Years of Follow-up
Number of Participants Who Died From Coronary Heart Disease
Number of Participants Who Died From Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up
+10 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Vitamin D placebo + fish oilActive Control2 Interventions
Group II: Vitamin D + fish oilActive Control2 Interventions
Group III: Vitamin D + fish oil placeboActive Control2 Interventions
Group IV: Vitamin D placebo + fish oil placeboPlacebo Group2 Interventions

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,669 Previous Clinical Trials
11,851,945 Total Patients Enrolled
Office of Dietary Supplements (ODS)NIH
54 Previous Clinical Trials
28,616 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,384 Previous Clinical Trials
626,817 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
867 Previous Clinical Trials
649,100 Total Patients Enrolled
Pharmavite LLCIndustry Sponsor
10 Previous Clinical Trials
943 Total Patients Enrolled
Pronova BioPharmaIndustry Sponsor
22 Previous Clinical Trials
5,861 Total Patients Enrolled
BASFIndustry Sponsor
13 Previous Clinical Trials
29,054 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,086,226 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,772,028 Total Patients Enrolled
Julie E. Buring, ScDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Omega-3 Fatty Acids (Omega-3 Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT01169259 — Phase 3
Cardiovascular Disease Research Study Groups: Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo, Vitamin D + fish oil, Vitamin D + fish oil placebo
Cardiovascular Disease Clinical Trial 2023: Omega-3 Fatty Acids Highlights & Side Effects. Trial Name: NCT01169259 — Phase 3
Omega-3 Fatty Acids (Omega-3 Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01169259 — Phase 3
~1678 spots leftby Dec 2025
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