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Omega-3 Fatty Acid Supplement

ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids for Cognitive Decline (VITAL-Cog Trial)

N/A
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change over two assessments (baseline, 2.8 years)
Awards & highlights

VITAL-Cog Trial Summary

This trial is investigating whether taking daily dietary supplements of vitamin D3 or omega-3 fatty acids reduces the risk of developing cancer, heart disease, and stroke. This ancillary study will examine whether vitamin D or fish oil is associated with cognitive decline in older participants.

Eligible Conditions
  • Cognitive Decline

VITAL-Cog Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change over two assessments (baseline, 2.8 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change over two assessments (baseline, 2.8 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Global Composite Score for Cognitive Decline
Secondary outcome measures
Change in Episodic Memory Score for Cognitive Decline
Change in Executive Function Score for Cognitive Decline
Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline.

VITAL-Cog Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: ACTIVE Vitamin D + ACTIVE Omega-3 Fatty AcidsActive Control2 Interventions
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]).
Group II: ACTIVE Vitamin D + PLACEBO Omega-3 Fatty AcidsActive Control2 Interventions
ACTIVE Vitamin D = Vitamin D3, one 2000 IU capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day
Group III: PLACEBO Vitamin D + ACTIVE Omega-3 Fatty AcidsActive Control2 Interventions
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]).
Group IV: PLACEBO Vitamin D + PLACEBO Omega-3 Fatty AcidsPlacebo Group2 Interventions
PLACEBO Vitamin D, one capsule/day; PLACEBO Omega-3 Fatty Acids, one capsule/day

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,017,501 Total Patients Enrolled
32 Trials studying Cognitive Decline
19,665 Patients Enrolled for Cognitive Decline
Brigham and Women's HospitalLead Sponsor
1,615 Previous Clinical Trials
11,467,406 Total Patients Enrolled
5 Trials studying Cognitive Decline
15,411 Patients Enrolled for Cognitive Decline

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Scientific ReportsJournal
Effect of Vitamin D on Cognitive Decline: Results from Two Ancillary Studies of the VITAL Randomized Trial
Kang, Jae H., Chirag M. Vyas, Olivia I. Okereke, Soshiro Ogata, Michelle Albert, I.-Min Lee, Denise D’Agostino, et al.. 2021. “Effect of Vitamin D on Cognitive Decline: Results from Two Ancillary Studies of the VITAL Randomized Trial”. Scientific Reports. Springer Science and Business Media LLC. doi:10.1038/s41598-021-02485-8.
clinicaltrials.govStudy
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Jae Hee Kang 2011. "A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01669915.
~252 spots leftby Apr 2025
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