Folic Acid and Omega -3 Fatty Acid Supplementation in Depressed Older Adults

Study Overview
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Brief Summary
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Our specific aim is to determine the impact of folic acid and omega-3 supplementation on the severity of depressive symptoms among depressed adults aged 65 and above.

Official Title
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Randomized Double-blind Controlled Clinical Trial to Assess the Impact of Folic Acid and Omega-3 Fatty Acids Supplementation on the Severity of Depressive Symptoms in Older Adults With Identified Depression

Conditions
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Depression

Intervention / Treatment
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* Dietary Supplement: folic acid
* Dietary Supplement: omega-3
* Dietary Supplement: vit B12
* Other: folic acid placebo
* Other: omega-3 placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65+ (year of birth -1942 or below) Depression (as defined by the DSM-IV diagnostic criteria for depression: major or minor depression or dysthymia) Exclusion Criteria: Co-existing psychiatric disorder (except anxiety disorders) Moderate and severe cognitive impairment Current treatment with anticoagulants, antithrombotics and fibrinolytics Current severe angina with exertion Chronic renal insufficiency Liver cirrhosis Alcohol or drug abuse

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: omega-3, folic acid, vitB12<br>folic acid (1600 mcg per day), and omega-3 (2000 mg per day: active docosahexaenoic acid (DHA) and eicosapentanoic acid (EPA), proportion 1:1), vitamin B12 (1000 mcg per day) | Dietary Supplement: folic acid<br> <br> Dietary Supplement: omega-3<br> <br> Dietary Supplement: vit B12<br> <br> |
| Experimental: omega-3, folic acid placebo, vit B12<br>omega-3,folic acid placebo (starch), vitamin B12 (1000 mcg per day) | Dietary Supplement: omega-3<br> <br> Dietary Supplement: vit B12<br> <br> Other: folic acid placebo<br> <br> |
| Experimental: omega-3 placebo, folic acid, vit B12<br>folic acid, omega-3 placebo(canola oil),vitamin B12 (1000 mcg per day) | Dietary Supplement: folic acid<br> <br> Dietary Supplement: vit B12<br> <br> Other: omega-3 placebo<br> <br> |
| Experimental: omega-3 placebo, folic acid placebo, vit B12<br>omega-3 placebo (canola oil),folic acid placebo (starch), vitamin B12 (1000 mcg per day) | Dietary Supplement: vit B12<br> <br> Other: folic acid placebo<br> <br> Other: omega-3 placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the severity of depressive symptoms |  | baseline, 4th , 8th and 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cognitive status |  | baseline, 4th, 8th, and 12th week | 
| nutritional status |  | baseline and end of study | 
| possible side effects |  | baseline, 4th, 8th, and 12th week |