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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLacebo | Placebo Comparator | Participants received placebo capsules daily for the duration of the study |
|
| Low dose Omega 3 | Experimental | Participants received 700 mg/day of omega 3 |
|
| High dose omega 3 | Experimental | Participants received 2150 mg/day of omega 3 fatty acids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo |
| |
| Low dose Omega 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D | serum 25-hydroxyvitamin D | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret M Harris, PhD MS HC | University of Colorado, Colorado Springs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Colorado Springs | Colorado Springs | Colorado | 80918 | United States |
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.
After publication of primary results and within 3 years of that publication.
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.
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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The coordinators recruiting and measuring
| Dietary Supplement |
700 mg/day omega 3 fatty acids |
|
| High dose Omega 3 | Dietary Supplement | 2150 mg/day omega 3 fatty acids |
|
| Baseline to end of intervention (90 days) |
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |