A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
VITAL-Cog
2 other identifiers
interventional
3,424
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2011
CompletedFirst Submitted
Initial submission to the registry
August 17, 2012
CompletedFirst Posted
Study publicly available on registry
August 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedResults Posted
Study results publicly available
April 21, 2023
CompletedApril 21, 2023
March 1, 2023
4.7 years
August 17, 2012
January 8, 2023
March 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Global Composite Score for Cognitive Decline
We administered by telephone, eight cognitive tests (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-Part A); 7. OTMT-Part B; 8.Digit span backwards). The primary endpoint was the change over time (last assessment score minus the baseline assessment score) in GLOBAL COMPOSITE SCORE (average of Z-scores of component tests); for both baseline and last assessment Z-scores, a mean Z-score of 0 represents the mean and the higher the Z-score, the better the overall cognitive performance across the tests. The primary endpoint was a difference of two Z-scores, so a value of 0 means no change over time, a positive value means an increase over time and a negative value means a decrease (or "decline") over time, for clinical significance, 1 year of aging is associated with a primary endpoint value of -0.004.
Change over two assessments (baseline, 2.8 years).
Secondary Outcomes (3)
Change in Episodic Memory Score for Cognitive Decline
Change over two assessments (baseline, 2.8 years)
Change in Executive Function Score for Cognitive Decline
Change over two assessments (baseline, 2.8 years)
Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.
Change over two assessments (baseline, 2.8 years)
Study Arms (4)
ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
ACTIVE COMPARATORACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/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 Vitamin D + PLACEBO Omega-3 Fatty Acids
ACTIVE COMPARATORACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
ACTIVE COMPARATORPLACEBO Vitamin D, one capsule/day; ACTIVE Omega-3 Fatty Acids = Omacor, one 1-gram capsule/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 \[DHA\]).
PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
PLACEBO COMPARATORPLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
Interventions
Vitamin D3 (cholecalciferol), 2000 IU per day
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 \[DHA\]).
Vitamin D placebo
Fish oil placebo
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (1)
Kang JH, Vyas CM, Okereke OI, Ogata S, Albert M, Lee IM, D'Agostino D, Buring JE, Cook NR, Grodstein F, Manson JE. Effect of vitamin D on cognitive decline: results from two ancillary studies of the VITAL randomized trial. Sci Rep. 2021 Dec 1;11(1):23253. doi: 10.1038/s41598-021-02485-8.
PMID: 34853363DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jae Hee Kang
- Organization
- Brigham and Women's Hospital;181 Longwood Ave; Boston, MA 02115
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
August 17, 2012
First Posted
August 21, 2012
Study Start
September 14, 2011
Primary Completion
June 8, 2016
Study Completion
December 31, 2021
Last Updated
April 21, 2023
Results First Posted
April 21, 2023
Record last verified: 2023-03