Omega-3 Supplementation and Mental Health in College Students (OMEGA-MH)

March 7, 2026 updated by: Margaret Harris, University of Colorado, Colorado Springs

Impact of Omega-3 Supplementation on Omega-3 Status, Vitamin D and Mood in College Students

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 3-arm randomized design was employed where participants took 2 pills daily for 90 days. The first arm was a placebo, second arm was a low dose omega 3 and third arm was high dose omega 3. Mental health outcomes were measured using the GAD 7 questionnaire that measured anxiety, PHQ-9 which measured depression, and MSQ (Medical Symptoms Questionnaire) that assessed overall bodily symptoms. Vitamin D levels were also assessed as a secondary outcome.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • University of Colorado Colorado Springs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • currently is taking steroid medications
  • had surgery within the last 2 weeks or plans on having surgery within the next 3 months
  • currently taking blood thinning medications
  • takes NSAIDS regularly
  • currently using a weight loss drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLacebo
Participants received placebo capsules daily for the duration of the study
Dietary supplement: Placebo
Placebo
Experimental: Low dose Omega 3
Participants received 700 mg/day of omega 3
Dietary supplement: Low dose Omega 3
700 mg/day omega 3 fatty acids
Experimental: High dose omega 3
Participants received 2150 mg/day of omega 3 fatty acids
Dietary supplement: High dose Omega 3
2150 mg/day omega 3 fatty acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: Baseline to end of intervention (90 days)
GAD-7 (Summed 0-21 with higher scores indicating more anxiety)
Baseline to end of intervention (90 days)
Depression Symptoms
Time Frame: Baseline to end of intervention (90 days)
PHQ-9 (Summed for a score of 0-27, the higher the score the more depression)
Baseline to end of intervention (90 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitamin D
Time Frame: Baseline to end of intervention (90 days)
serum 25-hydroxyvitamin D
Baseline to end of intervention (90 days)
Medical Symptom Burden
Time Frame: Baseline to end of intervention (90 days)
Medical Symptoms Questionnaire (MSQ), summed score 0-100, the lower the score the better health. Optimal health is 10 or less
Baseline to end of intervention (90 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Colorado Springs

Investigators

  • Principal Investigator: Margaret M Harris, PhD MS HC, University of Colorado, Colorado Springs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2024

Primary Completion (Actual)

December 12, 2025

Study Completion (Actual)

December 12, 2025

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

After publication of primary results and within 3 years of that publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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