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

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. Identifier: NCT00275418
Recruitment Status : Unknown
Verified January 2006 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
First Posted : January 12, 2006
Last Update Posted : January 12, 2006
Information provided by:
Bnai Zion Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: beta carotene from Dunaliella algae Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
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
Study Start Date : July 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   17 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT00275418

Contact: Matthias Carlebach, MD + 972-4-8359426
Contact: Alexandra Lavy, MD + 972-4-8359736

Bnai Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: Matthias Carlebach, MD    + 972-4-8359426   
Contact: Alexandra Lavy, MD    + 972-4-8359736   
Sub-Investigator: Matthias Carlebach, MD         
Sponsors and Collaborators
Bnai Zion Medical Center
Principal Investigator: Alexandra Lavy, MD Technion, Haifa, Israel Identifier: NCT00275418     History of Changes
Other Study ID Numbers: Beta Carotene 01
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: January 12, 2006
Last Verified: January 2006

Keywords provided by Bnai Zion Medical Center:
Crohn's disease
beta carotene

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Beta Carotene
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances