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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Jae Hee Kang, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01669915
First received: August 17, 2012
Last updated: March 21, 2013
Last verified: March 2013
History of Changes
  Purpose

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 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 Intervention
Cognitive Decline
 Dietary Supplement: vitamin D3
Drug: omega-3 fatty acids (fish oil)
Dietary Supplement: Vitamin D3 placebo
Dietary Supplement: Fish oil placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 3000
Study Start Date: August 2010
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D + fish oil 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]).
Active Comparator: Vitamin D + fish oil placebo Dietary Supplement: vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
Other Name: cholecalciferol
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 period
  4. indicate a willingness on the run-in phase to participate in a cognitive sub-study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669915

Locations
United States, Massachusetts
Boston, Massachusetts, United States
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute on Aging (NIA)
  More Information

Additional Information:
VITAL study website link  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jae Hee Kang, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01669915     History of Changes
Other Study ID Numbers: 2010P-000769, R01AG036755
Study First Received: August 17, 2012
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
 Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 17, 2013