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

NCT01653678 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25875

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D-3 (cholecalciferol), 2000 IU

DRUG

Omega-3 fatty acids (fish oil)

Omacor, 1 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 D placebo

DRUG

Fish oil placebo

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Howard D. Sesso, ScD, MPH · Brigham and Women's Hospital

  • John P. Forman, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
50 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2025-11-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01653678 on ClinicalTrials.gov