N/A
Completed N=3,424
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
Source: ClinicalTrials.gov NCT01669915 ↗Enrolled (actual)
3,424
Serious AEs
7.4%
Results posted
Apr 2023
Primary outcomePrimary: Change in Global Composite Score for Cognitive Decline — -0.24; -0.25; -0.25; -0.24 Z-score — p=0.31
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.
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 |
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. Informational only — not medical advice.