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NCT01669915 · ClinicalTrials.gov registry record · NA
A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 3,424
- Enrollment target
NCT01669915: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT01669915 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 3,424 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (144% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01669915, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 3,424 participants
- Enrollment target
Study 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.
Primary Outcome
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 compone
Interventions
- DIETARY_SUPPLEMENT vitamin D3
- DIETARY_SUPPLEMENT Vitamin D3 placebo
- DIETARY_SUPPLEMENT Fish oil placebo
- DRUG omega-3 fatty acids (fish oil)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,424 participants |
| Start Date | 2011-09-14 |
| Est. Completion | 2021-12-31 |
| Phase | NA |
What the finished NCT01669915 record still lists
NCT01669915 is an interventional study that assigns participants to a tested intervention. Its 3,424 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (144% higher).
The record links to 0 conditions, and to 4 interventions - of which vitamin D3 is the first listed.
NCT01669915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01669915 about?
NCT01669915 is a clinical study titled "A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline". 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 dis...
What is the current status of trial NCT01669915?
This trial is currently completed. It is a NA study. The enrollment target is 3,424 participants. The study started on 2011-09-14. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT01669915?
The interventions under investigation include: vitamin D3 (DIETARY_SUPPLEMENT), Vitamin D3 placebo (DIETARY_SUPPLEMENT), Fish oil placebo (DIETARY_SUPPLEMENT), omega-3 fatty acids (fish oil) (DRUG).
Who is sponsoring clinical trial NCT01669915?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01669915's enrollment target sits among peer trials
3,424 37th of 2000 higher than 1,964 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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