N/A
N=3,424
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT01669915 ↗Enrolled (actual)
3,424
Serious AEs
7.4%
Results posted
Apr 2023
Primary outcome: Primary: Change in Global Composite Score for Cognitive Decline — -0.24; -0.25; -0.25; -0.24 Z-score — p=0.31
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- vitamin D3 (Dietary_supplement); omega-3 fatty acids (fish oil) (Drug); Vitamin D3 placebo (Dietary_supplement); Fish oil placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Global Composite Score for Cognitive Decline |
-0.24; -0.25; -0.25; -0.24 | 0.31 |
| SECONDARY Change in Episodic Memory Score for Cognitive Decline |
0.00; -0.02; -0.03; 0.02 | 0.49 |
| SECONDARY Change in Executive Function Score for Cognitive Decline |
-0.48; -0.48; -0.47; -0.49 | 0.23 |
| SECONDARY Change in Telephone Interview of Cognitive Status (TICS) for Cognitive Decline. |
0.12; 0.07; 0.005; 0.18 | 0.46 |
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.
Eligibility Criteria
Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study:
- are aged 60 or more
- have no hearing impairment
- indicate a willingness on the run-in phase to participate in a cognitive sub-study.
Data sourced from ClinicalTrials.gov (NCT01669915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.