Trial record 1 of 1 for:    VITAL-COG
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A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline (VITAL-Cog)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jae Hee Kang, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01669915
First received: August 17, 2012
Last updated: May 29, 2014
Last verified: May 2014

August 17, 2012
May 29, 2014
August 2010
October 2017   (final data collection date for primary outcome measure)
Cognitive Decline [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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.

Cognitive Decline [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01669915 on ClinicalTrials.gov Archive Site
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A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cognitive Decline
  • Dietary Supplement: vitamin D3
    Vitamin D3 (cholecalciferol), 2000 IU per day
    Other Name: cholecalciferol
  • 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
  • Dietary Supplement: Fish oil placebo
    Fish oil placebo
  • Active Comparator: Vitamin D + fish oil
    Interventions:
    • Dietary Supplement: vitamin D3
    • Drug: omega-3 fatty acids (fish oil)
  • Active Comparator: Vitamin D + fish oil placebo
    Interventions:
    • Dietary Supplement: vitamin D3
    • Dietary Supplement: Fish oil placebo
  • Active Comparator: Vitamin D placebo + fish oil
    Interventions:
    • Drug: omega-3 fatty acids (fish oil)
    • Dietary Supplement: Vitamin D3 placebo
  • Placebo Comparator: Vitamin D placebo + fish oil placebo
    Interventions:
    • Dietary Supplement: Vitamin D3 placebo
    • Dietary Supplement: Fish oil placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3226
October 2017
October 2017   (final data collection date for primary outcome measure)

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. provide a blood sample or fill out a food frequency questionnaire in the run-in period
  4. indicate a willingness on the run-in phase to participate in a cognitive sub-study.
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01669915
2010P-000769, R01AG036755
No
Jae Hee Kang, Brigham and Women's Hospital
Brigham and Women's Hospital
National Institute on Aging (NIA)
Not Provided
Brigham and Women's Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP