CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,424 enrolled
Drug / intervention
omega-3 fatty acids (fish oil) +3 moredrug
Likely dose
omega-3 fatty acids (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/NCT01669915
NCT01669915N/ACompleted

A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline

Brigham and Women's Hospital·interventional·Posted Aug 21, 2012·Updated Apr 21, 2023

In Brief

A clinical study evaluating vitamin D3, omega-3 fatty acids (fish oil), and 2 other interventions for Cognitive Decline. Completed, enrolled 3,424 participants across 1 site.

Detailed 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. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil is associated with cognitive decline in 3000 older participants of VITAL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 21, 2012
Enrollment StartSep 14, 2011
Primary CompletionJun 8, 2016
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.9 years ago

Interventions

vitamin D3dietary

Vitamin D3 (cholecalciferol), 2000 IU per day

omega-3 fatty acids (fish oil)drug

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 D3 placebodietary

Vitamin D placebo

Fish oil placebodietary

Fish oil placebo