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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Bnai Zion Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT00275418
First received: January 10, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  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

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

Ages Eligible for Study:   17 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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 April 15, 2014