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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00480207 |
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Date of registration:
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28/05/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Folic Acid and Omega -3 Fatty Acid Supplementation in Depressed Older Adults
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Scientific title:
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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 |
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Date of first enrolment:
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May 2007 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00480207 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Israel
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Contacts
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Name:
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Danit R Shahar, RD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ben-Gurion University of the Negev |
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Name:
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Alex Palatnik, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beersheva Mental Health Center |
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Name:
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Larissa German, MD, MMedSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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The S. Daniel Abraham International Center for Health and Nutrition |
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Key inclusion & exclusion 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
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depression
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Intervention(s)
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Dietary Supplement: omega-3
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Other: omega-3 placebo
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Dietary Supplement: vit B12
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Dietary Supplement: folic acid
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Other: folic acid placebo
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Primary Outcome(s)
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the severity of depressive symptoms
[Time Frame: baseline, 4th , 8th and 12th week]
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Secondary Outcome(s)
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nutritional status
[Time Frame: baseline and end of study]
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cognitive status
[Time Frame: baseline, 4th, 8th, and 12th week]
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possible side effects
[Time Frame: baseline, 4th, 8th, and 12th week]
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Secondary ID(s)
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ICHN-4413
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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