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Completed

NCT Number: NCT07391254

Omega-3 Supplementation and Mental Health 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.

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Key information

Age range

18 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Colorado Springs

Colorado Springs, Colorado, 80918, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

Placebo

Low dose Omega 3

Dietary Supplement

700 mg/day omega 3 fatty acids

High dose Omega 3

Dietary Supplement

2150 mg/day omega 3 fatty acids

Primary outcomes

  1. Anxiety

    Time frame: Baseline to end of intervention (90 days)

    GAD-7 (Summed 0-21 with higher scores indicating more anxiety)

  2. 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)

Secondary outcomes

  1. Vitamin D

    Time frame: Baseline to end of intervention (90 days)

    serum 25-hydroxyvitamin D

  2. 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Colorado Springs

Other

Registry information

Official study title

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

Acronym: OMEGA-MH

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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