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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

VITAL 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.Check my eligibility

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.See study design

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.

VITAL Trial 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.

VITAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years, excluding first 2 years of follow-up

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Invasive Cancer of Any Type

Number of Participants With a Major Cardiovascular Event

Secondary outcome measures

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 outcome measures

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

VITAL 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,608 Previous Clinical Trials

11,444,006 Total Patients Enrolled

Office of Dietary Supplements (ODS)NIH

52 Previous Clinical Trials

28,576 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,339 Previous Clinical Trials

623,519 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other examples where Vitamin D and fish oil have been studied together?

"There are currently 18 separate clinical trials investigating the efficacy of Vitamin d + fish oil. Of those, 4 have progressed to Phase 3. While the majority of these studies are based in Boston, Massachusetts, there are a total of 35 locations running trials for this treatment."

Answered by AI

Are we still able to enroll more people in this program?

"According to the website, this study has not been recruiting new patients for some time. Although the last update was on May 18th, 2022, the study was first posted over 12 years ago on July 1st, 2010. There are, however, 939 other trials that are still recruiting patients."

Answered by AI

Is this research project the first of its kind?

"Currently, there are 18 separate ongoing studies investigating the effects of Vitamin d + fish oil. These trials are being conducted in 7 cities and 11 countries. The first study was sponsored by Abbott and completed Phase 4 drug approval in 2005. A total of 15480 patients were involved. Since then, 137 more trials have been completed."

Answered by AI

Does the FDA recognize any benefits to taking Vitamin D + fish oil supplements?

"There is some data supporting the efficacy of Vitamin d + fish oil, and it has received multiple rounds of support for safety, so it is estimated to be a 3 on a scale of 1 to 3."

Answered by AI

What are researchers hoping to discover with this trial?

"The objectives of this long-term clinical assessment are to evaluate the Number of Participants With a Major Cardiovascular Event and also to compare rates of Secondary objectives which include Number of Female Participants With Breast cancer, Number of Participants With Myocardial Infarction, and Number of Male Participants With Prostate cancer."

Answered by AI

How many people will be given the opportunity to participate in this clinical trial?

"This study is no longer recruiting patients. It was first posted on July 1st, 2010 and was last updated on May 18th, 2022. For patients searching for other trials, there are 921 trials for malignancies and 18 trials for Vitamin d + fish oil currently admitting participants."

Answered by AI

Recent research and studies

Contemporary Clinical TrialsJournal

Baseline Characteristics of Participants in the Vitamin D and Omega-3 Trial (VITAL)

Bassuk, Shari S., JoAnn E. Manson, I-Min Lee, Nancy R. Cook, William G. Christen, Vadim Y. Bubes, David S. Gordon, et al.. 2016. “Baseline Characteristics of Participants in the Vitamin D and Omega-3 Trial (VITAL)”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2015.12.022.

The Journal of Steroid Biochemistry and Molecular BiologyJournal

Update on the Vitamin D and Omega-3 Trial (VITAL)

Pradhan, Aruna D., and JoAnn E. Manson. 2016. “Update on the Vitamin D and Omega-3 Trial (VITAL)”. The Journal of Steroid Biochemistry and Molecular Biology. Elsevier BV. doi:10.1016/j.jsbmb.2015.04.006.

Contemporary Clinical TrialsJournal

The Vitamin D and Omega-3 Trial (VITAL): Rationale and Design of a Large Randomized Controlled Trial of Vitamin D and Marine Omega-3 Fatty Acid Supplements for the Primary Prevention of Cancer and Cardiovascular Disease

Manson, JoAnn E., Shari S. Bassuk, I-Min Lee, Nancy R. Cook, Michelle A. Albert, David Gordon, Elaine Zaharris, et al.. 2012. “The Vitamin D and Omega-3 Trial (VITAL): Rationale and Design of a Large Randomized Controlled Trial of Vitamin D and Marine Omega-3 Fatty Acid Supplements for the Primary Prevention of Cancer and Cardiovascular Disease”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2011.09.009.

New England Journal of MedicineJournal