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Clinical trial

Effect of Vitamin D and Omega-3 Fatty Acids on Blood Pressure and Hypertension

ID
Name
2010-P-002880
Description
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.
Trial arms
Trial start
2011-11-01
Estimated PCD
2025-01-01
Trial end
2025-01-01
Status
Active (not recruiting)
Treatment
Vitamin D-3 (cholecalciferol), 2000 IU
Arms:
Vitamin D + fish oil, Vitamin D + fish oil placebo
Other names:
cholecalciferol
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 \[DHA\])
Arms:
Vitamin D + fish oil, Vitamin D placebo + fish oil
Vitamin D placebo
Arms:
Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo
Fish oil placebo
Arms:
Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo
Size
25875
Primary endpoint
Change in blood pressure
Two years
Incident hypertension
5 years
Changes in 25-hydroxy-vitamin D levels
2 years
Changes in fatty acid levels
2 years
Changes in biomarkers related to blood pressure
2 years
Eligibility criteria
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..
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 25875, 'type': 'ACTUAL'}}
Updated at
2024-03-15

1 organization

2 products

1 indication

Organization
Brigham and Women's Hospital
Product
Omega-3 fatty acids
Indication
Hypertension
Product
Fish oil