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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00480207

Enrollment

Registered

2007-05-30

Start date

2007-05-31

Completion date

2008-10-31

Last updated

2012-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

DIETARY_SUPPLEMENTfolic acid

DIETARY_SUPPLEMENTomega-3

DIETARY_SUPPLEMENTvit B12

OTHERfolic acid placebo

OTHERomega-3 placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
the severity of depressive symptoms	baseline, 4th , 8th and 12th week

Secondary

Measure	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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026