Active — Not RecruitingNot Applicable

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

United States25,875 participantsStarted 2011-11

Plain-language summary

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.

Who can participate

Age range50 Years – 99 Years

SexALL

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Participants eligible and willing to participate in the main VITAL trial (NCT 01169259) who meet the following criteria are eligible to participate in the VITAL Hypertension ancillary study: all participants with no baseline history of hypertension and, for home visits in the subcohort of 1,000 participants, those living in selected cities throughout the U.S..

What they're measuring

Change in blood pressure

Timeframe: Two years

Incident hypertension

Timeframe: 5 years

Changes in 25-hydroxy-vitamin D levels

Timeframe: 2 years

Changes in fatty acid levels

Timeframe: 2 years

Changes in biomarkers related to blood pressure

Timeframe: 2 years

Trial details

NCT IDNCT01653678

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11

View on ClinicalTrials.gov More Hypertension trials