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

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ClinicalTrials.gov Identifier: NCT01669915
Recruitment Status : Active, not recruiting
First Posted : August 21, 2012
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Jae Hee Kang, Brigham and Women's Hospital

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
Cognitive Decline Dietary Supplement: vitamin D3 Drug: omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3992 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Study Start Date : August 2010
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Cognitive Decline [ Time Frame: 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.




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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 60 or more
  2. have no hearing impairment
  3. indicate a willingness on the run-in phase to participate in a cognitive sub-study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01669915


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

Additional Information:
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 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2012    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents