A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
NCT ID: NCT01669915
Last Updated: 2023-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
3424 participants
INTERVENTIONAL
2011-09-14
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
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ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
ACTIVE 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 \[DHA\]).
vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
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 Vitamin D + PLACEBO Omega-3 Fatty Acids
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
Fish oil placebo
Fish oil placebo
PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
PLACEBO 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 \[DHA\]).
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 \[DHA\]).
Vitamin D3 placebo
Vitamin D placebo
PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
Vitamin D3 placebo
Vitamin D placebo
Fish oil placebo
Fish oil placebo
Interventions
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vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day
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 \[DHA\]).
Vitamin D3 placebo
Vitamin D placebo
Fish oil placebo
Fish oil placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. have no hearing impairment
3. indicate a willingness on the run-in phase to participate in a cognitive sub-study.
60 Years
92 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Jae Hee Kang
Assistant Professor of Medicine
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
Related Links
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VITAL study website link
Other Identifiers
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2010P-000769
Identifier Type: -
Identifier Source: org_study_id
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