Omega-3 Supplementation and Mental Health in College Students
OMEGA-MH
Impact of Omega-3 Supplementation on Omega-3 Status, Vitamin D and Mood in College Students
1 other identifier
interventional
103
1 country
1
Brief Summary
This randomized, placebo-controlled double blinded study examined whether placebo, low- or high dose omega 3 fatty acid supplementation had associations with mental health symptoms and vitamin D status in college students aged 18-27.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2025
CompletedFirst Submitted
Initial submission to the registry
January 29, 2026
CompletedFirst Posted
Study publicly available on registry
February 5, 2026
CompletedMarch 10, 2026
March 1, 2026
1.3 years
January 29, 2026
March 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Anxiety
GAD-7 (Summed 0-21 with higher scores indicating more anxiety)
Baseline to end of intervention (90 days)
Depression Symptoms
PHQ-9 (Summed for a score of 0-27, the higher the score the more depression)
Baseline to end of intervention (90 days)
Secondary Outcomes (2)
Vitamin D
Baseline to end of intervention (90 days)
Medical Symptom Burden
Baseline to end of intervention (90 days)
Study Arms (3)
PLacebo
PLACEBO COMPARATORParticipants received placebo capsules daily for the duration of the study
Low dose Omega 3
EXPERIMENTALParticipants received 700 mg/day of omega 3
High dose omega 3
EXPERIMENTALParticipants received 2150 mg/day of omega 3 fatty acids
Interventions
Eligibility Criteria
You may qualify if:
- age 18-27 years
- if taking antidepressants or enrolled in therapy, needs to be stable with at least 6 months or more of stable medication dose use and regular therapy appointments
You may not qualify if:
- age younger than 18 and older than 27
- not willing to take two capsules daily for 90 days
- not willing to get bloodwork
- has a history of fainting during bloodwork
- not willing to have anthropometrics measured
- not willing to have daily text reminders sent to phone
- currently has regularly taken omega 3 daily for at least 6 months
- currently has regularly taken vitamin D supplementation daily for at least 6 months
- allergic or sensitive to fish
- will not like to deal with potential "fish burps"
- utilized mental health services for less than 6 months
- taken an antidepressant for less than 6 months
- currently actively takes benzodiazepines
- currently actively takes sedatives or tranquilizers
- Currently is taking steroid supplements
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Colorado Springs
Colorado Springs, Colorado, 80918, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret M Harris, PhD MS HC
University of Colorado, Colorado Springs
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The coordinators recruiting and measuring
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 29, 2026
First Posted
February 5, 2026
Study Start
August 29, 2024
Primary Completion
December 12, 2025
Study Completion
December 12, 2025
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After publication of primary results and within 3 years of that publication.
- Access Criteria
- Access to de-identified individual participant data will be provided to qualified researchers for the purpose of inclusion in systematic reviews and meta-analyses. Requests must be addressed to the main and backup contacts (Dr Harris and Dr Hutchins) via email (and will be reviewed by the research team). Requests must include a brief research proposal, statistical analysis plan, and evidence of IRB approval or exemption, as applicable. Approved requests will receive the de-identified data and supporting documents via a secure electronic transfer following execution of a data use agreement.
De-identified dataset, along with the study protocol, statistical analysis plan, informed consent document, and clinical study report, will be made available to qualified researched upon reasonable request. Data will be provided for purposes of research synthesis, including systematic reviews and meta- analyses, following investigator approval and execution of a data use agreement. All shared materials will be de-identified and limited to variables necessary to address the approved research question.