Mental HealthOMEGA-MHNCT07391254
Omega-3 Supplementation and Mental Health in College Students
A study testing Low dose Omega 3 and High dose Omega 3 in people with Mental Health and Vitamin D, run by University of Colorado, Colorado Springs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Vitamin D
- What is being tested?
- Low dose Omega 3 and High dose Omega 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2024to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Colorado Springs
Colorado Springs, Colorado, 80918
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health, Vitamin D
- Being tested
- Placebo, Low dose Omega 3, High dose Omega 3
- Keywords
- omega-3, Fish oil, mood, depression, anxiety, mental health, vitamin D, college students, young adults
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo
Low dose Omega 3Dietary supplement
700 mg/day omega 3 fatty acids
High dose Omega 3Dietary supplement
2150 mg/day omega 3 fatty acids
| Study group | Role | What they receive |
|---|---|---|
| PLacebo | Placebo comparator | Participants received placebo capsules daily for the duration of the study Receives: Dietary Supplement: Placebo |
| Low dose Omega 3 | Experimental | Participants received 700 mg/day of omega 3 Receives: Dietary Supplement: Low dose Omega 3 |
| High dose omega 3 | Experimental | Participants received 2150 mg/day of omega 3 fatty acids Receives: Dietary Supplement: High dose Omega 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
GAD-7 (Summed 0-21 with higher scores indicating more anxiety)
Measured: 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)
Measured: Baseline to end of intervention (90 days)
Secondary outcomes (2)
Vitamin D
serum 25-hydroxyvitamin D
Measured: Baseline to end of intervention (90 days)
Medical Symptom Burden
Medical Symptoms Questionnaire (MSQ), summed score 0-100, the lower the score the better health. Optimal health is 10 or less
Measured: Baseline to end of intervention (90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start29 Aug 2024
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Colorado Springs
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Harris, University of Colorado, Colorado Springs
- Investigators
- Margaret M Harris, PhD MS HC, Principal investigator, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391254
- Sponsor's protocol ID
- 2024-164
- Acronym
- OMEGA-MH
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Omega-3 Supplementation on Omega-3 Status, Vitamin D and Mood in College Students
- ClinicalTrials.gov ID
- NCT07391254
- Acronym / sponsor ID
- OMEGA-MH / 2024-164
- Conditions
- Mental Health, Vitamin D
- Keywords
- omega-3, Fish oil, mood, depression, anxiety, mental health, vitamin D, college students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of Colorado, Colorado SpringsUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLacebo | Placebo comparator | Dietary Supplement: PlaceboParticipants received placebo capsules daily for the duration of the study |
| Low dose Omega 3 | Experimental | Dietary Supplement: Low dose Omega 3Participants received 700 mg/day of omega 3 |
| High dose omega 3 | Experimental | Dietary Supplement: High dose Omega 3Participants received 2150 mg/day of omega 3 fatty acids |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Dietary supplement | PLacebo |
| Low dose Omega 3700 mg/day omega 3 fatty acids | Dietary supplement | Low dose Omega 3 |
| High dose Omega 32150 mg/day omega 3 fatty acids | Dietary supplement | High dose omega 3 |
Primary outcome
Anxiety
Time frame: Baseline to end of intervention (90 days)
GAD-7 (Summed 0-21 with higher scores indicating more anxiety)
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)
2 secondary outcomes
Vitamin D
Time frame: Baseline to end of intervention (90 days)
Medical Symptom Burden
Time frame: Baseline to end of intervention (90 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret M Harris, PhD MS HC principal investigator
University of Colorado, Colorado Springs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose Omega 3 and High dose Omega 3 in people with Mental Health and Vitamin D, run by University of Colorado, Colorado Springs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Baseline to end of intervention (90 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.