N/A
Completed N=18,353
VITAL-DEP: Depression Endpoint Prevention in the VITamin D and OmegA-3 TriaL
Source: ClinicalTrials.gov NCT01696435 ↗Enrolled (actual)
18,353
Serious AEs
12.2%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants With a Depression Event — 609; 625; 651; 583 Participants — p=0.62
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Depression Event |
609; 625; 651; 583 | 0.62 |
| PRIMARY Mood Scores |
1.08; 1.13; 1.09; 1.11; 0.03; 0.03 | — |
Eligibility Criteria
Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study. These are the criteria specific for testing of the primary aims in the VITAL-DEP ancillary study:
- no current significant depressive symptoms
- no core major depressive disorder symptoms for a period of two or more weeks in the past two years
- no history of alcohol and/or substance abuse disorder active in the past 12 months, schizophrenia or other primary psychotic disorder, bipolar disorder, post-traumatic stress disorder or obsessive-compulsive disorder
- no current psychotherapy or current use of psychotropics (including non-prescription agents for the treatment of mood disorders), except for limited use of mild sedatives/hypnotics
- no history of major neurologic disorder or delirium episode in the past 12 months
- no history of clinical (i.e., overt and not sub-clinical) hypothyroidism diagnosis
Data sourced from ClinicalTrials.gov (NCT01696435). 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.