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

Last updated: March 30, 2023
Sponsor: Brigham and Women's Hospital
Overall Status: Completed

Phase

N/A

Condition

Mild Cognitive Impairment

Alzheimer's Disease

Dementia

Treatment

N/A

Clinical Study ID

NCT01669915
2010P-000769
R01AG036755
  • Ages 60-92
  • All Genders
  • Accepts Healthy Volunteers

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. 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 3424
Study Start date:
September 14, 2011
Estimated Completion Date:
December 31, 2021

Study Description

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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

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