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

This study has been completed.
Sponsor:
Collaborator:
The S. Daniel Abraham International Center for Health and Nutrition
Information provided by (Responsible Party):
Prof. RH Belmaker, Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00480207
First received: May 28, 2007
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Depression
 Dietary Supplement: folic acid
Dietary Supplement: omega-3
Dietary Supplement: vit B12
Other: folic acid placebo
Other: omega-3 placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • the severity of depressive symptoms [ Time Frame: baseline, 4th , 8th and 12th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cognitive status [ Time Frame: baseline, 4th, 8th, and 12th week ] [ Designated as safety issue: No ]
  • nutritional status [ Time Frame: baseline and end of study ] [ Designated as safety issue: No ]
  • possible side effects [ Time Frame: baseline, 4th, 8th, and 12th week ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: May 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480207

Locations
Israel
Mental Health Center
Beer-Sheva, Israel
Sponsors and Collaborators
Prof. RH Belmaker
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
  More Information

No publications provided

Responsible Party: Prof. RH Belmaker, Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT00480207     History of Changes
Other Study ID Numbers: ICHN-4413
Study First Received: May 28, 2007
Last Updated: November 5, 2012
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Folic Acid
Vitamin B Complex
Hydroxocobalamin
Vitamin B 12
 Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013