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NCT00275418 Clinical Trial

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

Crohn's Disease Clinical Trial

Official title:
Double-Blind Randomized Prospective Trial of Treatment With Natural Beta Carotene Vs. Placebo for Patients With Crohn's Disease in Remission

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00275418
Other study ID # Beta Carotene 01
Secondary ID
Status Recruiting
Phase Phase 3
First received January 10, 2006
Last updated January 10, 2006
Start date July 2002

Study information
Verified date January 2006
Source Bnai Zion Medical Center
Contact Matthias Carlebach, MD
Phone + 972-4-8359426
Email matthias.carlebach@b-zion.org.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• beta carotene from Dunaliella algae

Locations
Country Name City State
Israel Bnai Zion Medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary CDAI score measured 3-monthly during treatment
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