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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: |
NCT00275418 |
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Date of registration:
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10/01/2006 |
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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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Beta Carotene From Natural Source for Patients With Non-Active Crohn's Disease
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Scientific title:
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Double-Blind Randomized Prospective Trial of Treatment With Natural Beta Carotene Vs. Placebo for Patients With Crohn's Disease in Remission |
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Date of first enrolment:
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July 2002 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00275418 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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Phase:
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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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Matthias Carlebach, MD |
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Address:
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Telephone:
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+ 972-4-8359426 |
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Email:
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matthias.carlebach@b-zion.org.il |
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Affiliation:
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Name:
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Matthias Carlebach, MD |
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Address:
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Telephone:
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+ 972-4-8359426 |
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Email:
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matthias.carlebach@b-zion.org.il |
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Affiliation:
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Name:
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Alexandra Lavy, 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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Technion, Haifa, Israel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients with documented Crohn's disease in remission (CDAI<150) for at least two
months, age 17-75 years
Exclusion Criteria:
- active Crohn's disease (CDAI>150), partial bowel obstruction, impending surgery,
pregnancy, serious other diseases
Age minimum:
17 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: beta carotene from Dunaliella algae
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Primary Outcome(s)
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CDAI score measured 3-monthly during treatment
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Secondary ID(s)
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Beta Carotene 01
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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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