Omega-3 + Vitamin D for High Blood Pressure

Recruiting in Palo Alto (17 mi)

Overseen by John P. Forman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

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Trial Summary

What is the purpose of this trial?

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,875 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 VITAL Hypertension ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or omega-3 fatty acids are related to changes in blood pressure and hypertension.

Research Team

Howard D. Sesso, ScD, MPH

Principal Investigator

Brigham and Women's Hospital

John P. Forman, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

The VITAL Hypertension trial is for U.S. adults without a history of high blood pressure, cancer, heart disease, or stroke who are already part of the main VITAL study. It's focused on those willing to take daily supplements and located in certain cities where home visits can be conducted.

Inclusion Criteria

Participants eligible and willing to participate in the main VITAL trial (NCT 01169259)

Participants living in selected cities throughout the U.S. for home visits in the subcohort of 1,000 participants

You do not have a history of high blood pressure.

Treatment Details

Interventions

• Omega-3 fatty acids (fish oil) (Omega-3 Fatty Acids)
• Vitamin D-3 (cholecalciferol), 2000 IU (Vitamin D)

Trial Overview This study tests if daily vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can lower the risk of developing high blood pressure. Participants are randomly assigned to receive either one of these supplements or a placebo.

Participant Groups

Group I: Vitamin D + fish oil Active Control 2 Interventions

Group II: Vitamin D placebo + fish oil Active Control 2 Interventions

Group III: Vitamin D + fish oil placebo Active Control 2 Interventions

Group IV: Vitamin D placebo + fish oil placebo Placebo Group 2 Interventions

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco