Completed

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

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What is being tested

vitamin D3

+ omega-3 fatty acids (fish oil)

+ Fish oil placebo

Dietary SupplementDrug
Who is being recruted

Mental Disorders+1

+ Cognition Disorders

+ Neurocognitive Disorders

From 60 to 92 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: September 2011
See protocol details

Summary

Principal SponsorBrigham and Women's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 14, 2011

Actual date on which the first participant was enrolled.

Primary aim of annual rate of cognitive decline. Secondary aims will be addressed in sub-set of participants: 1) among participants, African-American race (African-Americans have high risk of Vitamin D deficiency) modifies effects of vitamin D3 supplementation on cognitive decline; 2) among a subset of participants, baseline plasma levels of vitamin D and omega-3 fatty acids modify agent effects.

Official TitleA Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
NCT01669915
Principal SponsorBrigham and Women's Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3424 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 92 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersCognition DisordersNeurocognitive DisordersCognitive Dysfunction

Criteria

Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study: 1. are aged 60 or more 2. have no hearing impairment 3. indicate a willingness on the run-in phase to participate in a cognitive sub-study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/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 \[DHA\]).

Group II

Active Comparator
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day

Group III

Active Comparator
PLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/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 \[DHA\]).

Group IV

Placebo
PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Brigham and Women's Hospital

Boston, United StatesOpen Brigham and Women's Hospital in Google Maps
CompletedOne Study Center