Beta Carotene From Natural Source for Patients With Non-Active Crohn's Disease
Recruitment status was Recruiting
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Purpose
Many inflammatory disorders in the body are linked to oxidative tissue damage. Anti-oxidants that are present in many natural food sources may provide protection from such damage.
Beta carotene is an anti-oxidant vitamin present in many fruits and vegetables. The algae Dunaliella is particularly rich in beta carotene.
In this prospective trial we want to investigate whether beta carotene from Dunaliella may prevent exacerbations of Crohn's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: beta carotene from Dunaliella algae |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Double-Blind Randomized Prospective Trial of Treatment With Natural Beta Carotene Vs. Placebo for Patients With Crohn's Disease in Remission |
- CDAI score measured 3-monthly during treatment
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2002 |
Patients with documented Crohn's disease who are at least 2 months in remission (CDAI<150) will be randomized to receive 60 mg beta carotene/day vs. placebo for 1 year.
The study medication will be taken in addition to regular treatment for Crohn's disease.
The protocol includes 5 visits (months 0, 3, 6, 9, 12). Each visit lasts 30-60 minutes and includes a brief interview, standard questionnaires, physical examination, and blood tests.
Exacerbation of Crohn's disease is defined as CDAI>150. The study hypothesis is that less patients treated with beta carotene will suffer an exacerbation than patients treated with placebo.
Eligibility| Ages Eligible for Study: | 17 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Matthias Carlebach, MD | + 972-4-8359426 | matthias.carlebach@b-zion.org.il |
| Contact: Alexandra Lavy, MD | + 972-4-8359736 | lavya@netvision.net.il |
| Israel | |
| Bnai Zion Medical Center | Recruiting |
| Haifa, Israel, 31048 | |
| Contact: Matthias Carlebach, MD + 972-4-8359426 matthias.carlebach@b-zion.org.il | |
| Contact: Alexandra Lavy, MD + 972-4-8359736 lavya@netvision.net.il | |
| Sub-Investigator: Matthias Carlebach, MD | |
| Principal Investigator: | Alexandra Lavy, MD | Technion, Haifa, Israel |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00275418 History of Changes |
| Other Study ID Numbers: | Beta Carotene 01 |
| Study First Received: | January 10, 2006 |
| Last Updated: | January 10, 2006 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Bnai Zion Medical Center:
|
Crohn's disease remission beta carotene |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Carotenoids Beta Carotene |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on June 18, 2013