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

Tracking Information
First Received Date ^ICMJE	August 17, 2012
Last Updated Date	March 21, 2013
Start Date ^ICMJE	August 2010
Estimated Primary Completion Date	July 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 20, 2012)	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.
Original Primary Outcome Measures ^ICMJE (submitted: August 17, 2012)	Cognitive Decline [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01669915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Official Title ^ICMJE	A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Cognitive Decline
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	3000
Estimated Completion Date	July 2016
Estimated Primary Completion Date	July 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study: are aged 65 or more have no hearing impairment provide a blood sample or fill out a food frequency questionnaire in the run-in period indicate a willingness on the run-in phase to participate in a cognitive sub-study.
Gender	Both
Ages	65 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01669915
Other Study ID Numbers ^ICMJE	2010P-000769, R01AG036755
Has Data Monitoring Committee	No
Responsible Party	Jae Hee Kang, Brigham and Women's Hospital
Study Sponsor ^ICMJE	Brigham and Women's Hospital
Collaborators ^ICMJE	National Institute on Aging (NIA)
Investigators ^ICMJE	Not Provided
Information Provided By	Brigham and Women's Hospital
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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