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Beta Carotene From Natural Source for Patients With Non-Active Crohn's Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2006 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275418
First Posted: January 12, 2006
Last Update Posted: January 12, 2006
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.
Information provided by:
Bnai Zion Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Resource links provided by NLM:


Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • CDAI score measured 3-monthly during treatment

Estimated Enrollment: 300
Study Start Date: July 2002
Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT00275418


Contacts
Contact: Matthias Carlebach, MD + 972-4-8359426 matthias.carlebach@b-zion.org.il
Contact: Alexandra Lavy, MD + 972-4-8359736 lavya@netvision.net.il

Locations
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         
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Alexandra Lavy, MD Technion, Haifa, Israel
  More Information

ClinicalTrials.gov Identifier: NCT00275418     History of Changes
Other Study ID Numbers: Beta Carotene 01
First Submitted: January 10, 2006
First Posted: January 12, 2006
Last Update Posted: January 12, 2006
Last Verified: January 2006

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
Protective Agents
Physiological Effects of Drugs
Provitamins
Vitamins
Micronutrients
Growth Substances