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

Primary Purpose

Crohn's Disease

Status

Unknown status

Phase

Phase 3

Locations

Israel

Study Type

Interventional

Intervention

beta carotene from Dunaliella algae

About this trial

This is an interventional prevention trial for Crohn's Disease focused on measuring Crohn's disease, remission, beta carotene

Eligibility Criteria

17 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bnai Zion Medical CenterRecruiting

Outcomes

Primary Outcome Measures

CDAI score measured 3-monthly during treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT00275418

First Posted

January 10, 2006

Last Updated

January 10, 2006

Sponsor

Bnai Zion Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00275418

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2006

Overall Recruitment Status

Unknown status

Study Start Date

July 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Bnai Zion Medical Center

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Crohn's disease, remission, beta carotene

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

300 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

beta carotene from Dunaliella algae

Primary Outcome Measure Information:

Title

CDAI score measured 3-monthly during treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Matthias Carlebach, MD

Phone

+ 972-4-8359426

matthias.carlebach@b-zion.org.il

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandra Lavy, MD

Phone

+ 972-4-8359736

lavya@netvision.net.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandra Lavy, MD

Organizational Affiliation

Technion, Haifa, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bnai Zion Medical Center

City

Haifa

ZIP/Postal Code

31048

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthias Carlebach, MD

Phone

+ 972-4-8359426

matthias.carlebach@b-zion.org.il

First Name & Middle Initial & Last Name & Degree

Alexandra Lavy, MD

Phone

+ 972-4-8359736

lavya@netvision.net.il

First Name & Middle Initial & Last Name & Degree

Matthias Carlebach, MD

12. IPD Sharing Statement

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

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