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

November 5, 2012 updated by: Prof. RH Belmaker

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-Sheva, Israel
        • Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Dietary supplement: folic acid
Dietary supplement: omega-3
Dietary supplement: vit B12
Experimental: omega-3, folic acid placebo, vit B12
omega-3,folic acid placebo (starch), vitamin B12 (1000 mcg per day)
Dietary supplement: omega-3
Dietary supplement: vit B12
Other: folic acid placebo
Experimental: omega-3 placebo, folic acid, vit B12
folic acid, omega-3 placebo(canola oil),vitamin B12 (1000 mcg per day)
Dietary supplement: folic acid
Dietary supplement: vit B12
Other: omega-3 placebo
Experimental: omega-3 placebo, folic acid placebo, vit B12
omega-3 placebo (canola oil),folic acid placebo (starch), vitamin B12 (1000 mcg per day)
Dietary supplement: vit B12
Other: folic acid placebo
Other: omega-3 placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. RH Belmaker

Collaborators

The S. Daniel Abraham International Center for Health and Nutrition

Investigators

  • Study Director: Danit R Shahar, RD PhD, Ben-Gurion University of the Negev
  • Principal Investigator: Alex Palatnik, MD, Beersheva Mental Health Center
  • Principal Investigator: Larissa German, MD, MMedSc, The S. Daniel Abraham International Center for Health and Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

May 28, 2007

First Submitted That Met QC Criteria

May 28, 2007

First Posted (Estimate)

May 30, 2007

Study Record Updates

Last Update Posted (Estimate)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICHN-4413

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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