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

NCT ID: NCT00480207

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-10-31

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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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omega-3, folic acid, vitB12

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)

Group Type EXPERIMENTAL

folic acid

Intervention Type DIETARY_SUPPLEMENT

omega-3

Intervention Type DIETARY_SUPPLEMENT

vit B12

Intervention Type DIETARY_SUPPLEMENT

omega-3, folic acid placebo, vit B12

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

Group Type EXPERIMENTAL

omega-3

Intervention Type DIETARY_SUPPLEMENT

vit B12

Intervention Type DIETARY_SUPPLEMENT

folic acid placebo

Intervention Type OTHER

omega-3 placebo, folic acid, vit B12

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

Group Type EXPERIMENTAL

folic acid

Intervention Type DIETARY_SUPPLEMENT

vit B12

Intervention Type DIETARY_SUPPLEMENT

omega-3 placebo

Intervention Type OTHER

omega-3 placebo, folic acid placebo, vit B12

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

Group Type EXPERIMENTAL

vit B12

Intervention Type DIETARY_SUPPLEMENT

folic acid placebo

Intervention Type OTHER

omega-3 placebo

Intervention Type OTHER

Interventions

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folic acid

Intervention Type DIETARY_SUPPLEMENT

omega-3

Intervention Type DIETARY_SUPPLEMENT

vit B12

Intervention Type DIETARY_SUPPLEMENT

folic acid placebo

Intervention Type OTHER

omega-3 placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The S. Daniel Abraham International Center for Health and Nutrition

OTHER

Sponsor Role collaborator

Prof. RH Belmaker

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. RH Belmaker

Prof. RH Belmaker

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Danit R Shahar, RD PhD

Role: STUDY_DIRECTOR

Ben-Gurion University of the Negev

Alex Palatnik, MD

Role: PRINCIPAL_INVESTIGATOR

Beersheva Mental Health Center

Larissa German, MD, MMedSc

Role: PRINCIPAL_INVESTIGATOR

The S. Daniel Abraham International Center for Health and Nutrition

Locations

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Mental Health Center

Beersheba, , Israel

Site Status

Countries

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Israel

References

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Appleton KM, Voyias PD, Sallis HM, Dawson S, Ness AR, Churchill R, Perry R. Omega-3 fatty acids for depression in adults. Cochrane Database Syst Rev. 2021 Nov 24;11(11):CD004692. doi: 10.1002/14651858.CD004692.pub5.

Reference Type DERIVED
PMID: 34817851 (View on PubMed)

Other Identifiers

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ICHN-4413

Identifier Type: -

Identifier Source: org_study_id