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

Phase 2

Completed

• Conditions: Depression
• Interventions: Dietary Supplement: folic acid; Dietary Supplement: omega-3; Dietary Supplement: vit B12; Other: folic acid placebo; Other: omega-3 placebo

• Registration Number: NCT00480207
• Lead Sponsor: Prof. RH Belmaker

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-05-28
• Study First Submitted QC: 2007-05-28
• Study First Posted: 2007-05-30
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Age 65+ (year of birth -1942 or below)
2. Depression (as defined by the DSM-IV diagnostic criteria for depression: major or minor depression or dysthymia)

Exclusion Criteria

1. Co-existing psychiatric disorder (except anxiety disorders)
2. Moderate and severe cognitive impairment
3. Current treatment with anticoagulants, antithrombotics and fibrinolytics
4. Current severe angina with exertion
5. Chronic renal insufficiency
6. Liver cirrhosis
7. Alcohol or drug abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
omega-3, folic acid, vitB12	folic acid	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)
omega-3, folic acid, vitB12	omega-3	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)
omega-3, folic acid, vitB12	vit B12	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)
omega-3, folic acid placebo, vit B12	omega-3	omega-3,folic acid placebo (starch), vitamin B12 (1000 mcg per day)
omega-3, folic acid placebo, vit B12	vit B12	omega-3,folic acid placebo (starch), vitamin B12 (1000 mcg per day)
omega-3, folic acid placebo, vit B12	folic acid placebo	omega-3,folic acid placebo (starch), vitamin B12 (1000 mcg per day)
omega-3 placebo, folic acid, vit B12	folic acid	folic acid, omega-3 placebo(canola oil),vitamin B12 (1000 mcg per day)
omega-3 placebo, folic acid, vit B12	vit B12	folic acid, omega-3 placebo(canola oil),vitamin B12 (1000 mcg per day)
omega-3 placebo, folic acid, vit B12	omega-3 placebo	folic acid, omega-3 placebo(canola oil),vitamin B12 (1000 mcg per day)
omega-3 placebo, folic acid placebo, vit B12	vit B12	omega-3 placebo (canola oil),folic acid placebo (starch), vitamin B12 (1000 mcg per day)
omega-3 placebo, folic acid placebo, vit B12	folic acid placebo	omega-3 placebo (canola oil),folic acid placebo (starch), vitamin B12 (1000 mcg per day)
omega-3 placebo, folic acid placebo, vit B12	omega-3 placebo	omega-3 placebo (canola oil),folic acid placebo (starch), vitamin B12 (1000 mcg per day)

Primary Outcome Measures

Name	Time	Method
the severity of depressive symptoms	baseline, 4th , 8th and 12th week

Secondary Outcome Measures

Name	Time	Method
nutritional status	baseline and end of study
possible side effects	baseline, 4th, 8th, and 12th week
cognitive status	baseline, 4th, 8th, and 12th week

Trial Locations

Locations (1)

Mental Health Center; 🇮🇱 Beer-Sheva, Israel