VITAL-Cog: A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Vitamin D + fish oil
|
Dietary Supplement: vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
Other Names:
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]).
|
| Active Comparator: Vitamin D + fish oil placebo
|
Dietary Supplement: vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
Other Names:
Dietary Supplement: Fish oil placebo
Fish oil placebo
|
| Active Comparator: Vitamin D placebo + fish oil
|
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]).
Dietary Supplement: Vitamin D3 placebo
Vitamin D placebo
|
| Placebo Comparator: Vitamin D placebo + fish oil placebo
|
Dietary Supplement: Vitamin D3 placebo
Vitamin D placebo
Dietary Supplement: Fish oil placebo
Fish oil placebo
|
Outcome Measures
Primary Outcome Measures
- Cognitive Decline [5 years]
By telephone, we will administer seven tests of cognitive function (1.Telephone Interview of Cognitive Status (TICS); 2.Delayed recall of the TICS 10-word list; 3.East Boston Memory Test (EBMT); 4.Delayed recall of the EBMT; 5.Category fluency test (animal naming test); 6.Oral Trail Making Test (OTMT); 7.Digit span backwards). These interviews will be repeated to allow evaluation of cognitive decline. The primary endpoint for VITAL-Cog will be the change over time in GLOBAL COMPOSITE SCORE, calculated by averaging the z-scores for the component tests for each participant. However, we will also analyze the individual cognitive tests as additional secondary outcomes. The two key secondary endpoints are change over time in the EPISODIC MEMORY SCORE combining z-scores of the immediate and delayed recalls of both the EBMT and the TICS 10-word list; and the EXECUTIVE FUNCTION SCORE, based on the z-scores of category fluency and OTMT.
Eligibility Criteria
Criteria
Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study:
-
are aged 60 or more
-
have no hearing impairment
-
indicate a willingness on the run-in phase to participate in a cognitive sub-study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Boston | Massachusetts | United States |
Sponsors and Collaborators
- Brigham and Women's Hospital
- National Institute on Aging (NIA)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2010P-000769
- R01AG036755