Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01696435 · ClinicalTrials.gov registry record · NA
VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 18,353
- Enrollment target
NCT01696435: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT01696435 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 18,353 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1208% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01696435, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 18,353 participants
- Enrollment target
Study Summary
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 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: 1) reduces risk of clinical depressive syndrome, 2) yields better mood scores over time, compared to placebo.
Primary Outcome
Depression syndrome will be determined by presence of clinical diagnosis, treatment and/or above-threshold symptoms on mood questionnaire (e.g., PHQ) items. This is an event outcome, where the depression event was defined as a new self-report of physician/clinician-diagnosed depression, treatment (medication and/or counseling) for depression, or presence of clinically relevant depressive symptoms (PHQ-8 total score \>=10 points) on the annual study questionnaires that were administered over a me
Interventions
- DIETARY_SUPPLEMENT vitamin D3
- DIETARY_SUPPLEMENT Fish oil placebo
- DRUG omega-3 fatty acids (fish oil)
- DIETARY_SUPPLEMENT Vitamin D placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18,353 participants |
| Start Date | 2010-07 |
| Est. Completion | 2025-03-31 |
| Phase | NA |
What the finished NCT01696435 record still lists
NCT01696435 is an interventional study that assigns participants to a tested intervention. Its 18,353 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1208% higher).
The record links to 0 conditions, and to 4 interventions - of which vitamin D3 is the first listed.
NCT01696435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01696435 about?
NCT01696435 is a clinical study titled "VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL". The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 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 NCT01696435?
This trial is currently completed. It is a NA study. The enrollment target is 18,353 participants. The study started on 2010-07. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT01696435?
The interventions under investigation include: vitamin D3 (DIETARY_SUPPLEMENT), Fish oil placebo (DIETARY_SUPPLEMENT), omega-3 fatty acids (fish oil) (DRUG), Vitamin D placebo (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01696435?
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 NCT01696435's enrollment target sits among peer trials
18,353 11th of 2000 higher than 1,990 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04372875 · 18,500 participants · NA
Health Information Technology to Reduce Disparities in Adolescent Health Outcomes: A Pragmatic Trial
- NCT04110522 · 18,000 participants · NA
Psoriatic Arthritis D2P Screening
- NCT05513833 · 18,000 participants · NA
School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky
- NCT06802224 · 18,000 participants · Phase 4
The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia