Mental Health, Vitamin D
Conditions
Keywords
omega-3, Fish oil, mood, depression, anxiety, mental health, vitamin D, college students, young adults
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.
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Placebo
DIETARY_SUPPLEMENTLow dose Omega 3
700 mg/day omega 3 fatty acids
DIETARY_SUPPLEMENTHigh dose Omega 3
2150 mg/day omega 3 fatty acids
Sponsors
University of Colorado, Colorado Springs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The coordinators recruiting and measuring
Eligibility
Sex/Gender
ALL
Age
18 Years to 27 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Baseline to end of intervention (90 days) | GAD-7 (Summed 0-21 with higher scores indicating more anxiety) |
| Depression Symptoms | Baseline to end of intervention (90 days) | PHQ-9 (Summed for a score of 0-27, the higher the score the more depression) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D | Baseline to end of intervention (90 days) | serum 25-hydroxyvitamin D |
| Medical Symptom Burden | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMargaret M Harris, PhD MS HC
University of Colorado, Colorado Springs
Outcome results
None listed