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

65 Years
Open (Enrolling by invite only)
Cognitive Decline

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Trial Information

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

Inclusion Criteria

Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to
participate in this ancillary study:

1. are aged 65 or more

2. have no hearing impairment

3. provide a blood sample or fill out a food frequency questionnaire in the run-in

4. indicate a willingness on the run-in phase to participate in a cognitive sub-study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Cognitive Decline

Outcome Description:

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 every 1.5 years for a total of 3 assessments 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.

Outcome Time Frame:

5 years

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

August 2010

Completion Date:

July 2016

Related Keywords:

  • Cognitive Decline
  • Cognition Disorders



Boston, Massachusetts