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

Prof. RH Belmaker

Status and phase: Completed; Phase 3; Phase 2

Conditions: Depression

Treatments: Dietary Supplement: folic acid; Other: omega-3 placebo; Dietary Supplement: vit B12; Dietary Supplement: omega-3; Other: folic acid placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00480207

ICHN-4413

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 4 patient groups

omega-3, folic acid, vitB12

Experimental group

Description:

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)

Treatment:

Dietary Supplement: vit B12

Dietary Supplement: omega-3

Dietary Supplement: folic acid

omega-3, folic acid placebo, vit B12

Experimental group

Description:

omega-3,folic acid placebo (starch), vitamin B12 (1000 mcg per day)

Treatment:

Dietary Supplement: vit B12

Dietary Supplement: omega-3

Other: folic acid placebo

omega-3 placebo, folic acid, vit B12

Experimental group

Description:

folic acid, omega-3 placebo(canola oil),vitamin B12 (1000 mcg per day)

Treatment:

Other: omega-3 placebo

Dietary Supplement: vit B12

Dietary Supplement: folic acid

omega-3 placebo, folic acid placebo, vit B12

Experimental group

Description:

omega-3 placebo (canola oil),folic acid placebo (starch), vitamin B12 (1000 mcg per day)

Treatment:

Other: omega-3 placebo

Dietary Supplement: vit B12

Other: folic acid placebo