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

Cognitive Decline Clinical Trial

— VITAL-Cog  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669915
• Other study ID #: 2010P-000769
• Secondary ID: R01AG036755
• Status: Completed
• Phase: N/A
• Start date: September 14, 2011
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3424
• Est. completion date: December 31, 2021
• Est. primary completion date: June 8, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 92 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

Dietary Supplement:
• vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day

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
• Fish oil placebo
Fish oil placebo

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Global Composite Score for Cognitive Decline	We administered by telephone, eight cognitive tests (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-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.	Change over two assessments (baseline, 2.8 years).
Secondary	Change in Episodic Memory Score for Cognitive Decline	The outcome measure was change over time (last assessment score minus the baseline assessment score) in the EPISODIC MEMORY SCORE combining z-scores of 4 tests: the immediate and delayed recalls of both the East Boston Memory Test (EBMT) and the Telephone Interview of Cognitive Status (TICS) 10-word list; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.01.	Change over two assessments (baseline, 2.8 years)
Secondary	Change in Executive Function Score for Cognitive Decline	The outcome measure is change over time (last assessment score minus the baseline assessment score) in the EXECUTIVE FUNCTION SCORE combining z-scores of 4 tests: category fluency (animal naming), digit span backwards, and Oral Trails Making Test (OTMT)-Part A and OTMT-Part B; for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of +0.006.	Change over two assessments (baseline, 2.8 years)
Secondary	Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.	Change over time (last assessment score minus the baseline assessment score) on the TICS (0-41 points), a measure of general cognition. A higher value on the TICS represents better cognitive performance; for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.05	Change over two assessments (baseline, 2.8 years)

External Links

•   VITAL study website link