CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 290 enrolled
Drug / intervention
Fish oil +3 moredrug
Likely dose
Fish oil 840 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04070833
NCT04070833N/ACompleted
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Effects of Vitamin D and Omega-3 on Cerebrovascular Disease

Brigham and Women's Hospital·interventional·Posted Aug 28, 2019·Updated Aug 15, 2022

In Brief

A clinical study evaluating Vitamin D, Fish oil, and 2 other interventions for Stroke and Vitamin D. Completed, enrolled 290 participants.

Detailed Summary

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a completed randomized clinical trial in 25,875 U.S. men and women which investigated whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduced the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. Observational follow-up of participants is currently ongoing. The current study is being conducted among participants in VITAL who experience a stroke event during follow-up and will examine whether vitamin D or omega-3 fatty acid supplementation impact post-stroke outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Vitamin D
Countries--
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 28, 2019
Enrollment StartAug 1, 2016
Primary CompletionSep 17, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.8 years ago

Interventions

Vitamin Ddietary

Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol

Fish oildrug

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 \[DHA\])

Vitamin D placebodietary

Vitamin D placebo

Fish oil placebodrug

Fish oil placebo