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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00480207
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : November 6, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : May 2007
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. the severity of depressive symptoms [ Time Frame: baseline, 4th , 8th and 12th week ]

Secondary Outcome Measures :
  1. cognitive status [ Time Frame: baseline, 4th, 8th, and 12th week ]
  2. nutritional status [ Time Frame: baseline and end of study ]
  3. possible side effects [ Time Frame: baseline, 4th, 8th, and 12th week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Prof. RH Belmaker, Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT00480207     History of Changes
Other Study ID Numbers: ICHN-4413
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: November 6, 2012
Last Verified: November 2012

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