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

NCT ID: NCT00275418

Last Updated: 2006-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Brief Summary

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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

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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beta carotene from Dunaliella algae

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bnai Zion Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Alexandra Lavy, MD

Role: PRINCIPAL_INVESTIGATOR

Technion, Haifa, Israel

Locations

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Bnai Zion Medical Center

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Matthias Carlebach, MD

Role: CONTACT

[email protected]
+ 972-4-8359426

Alexandra Lavy, MD

Role: CONTACT

[email protected]
+ 972-4-8359736

Facility Contacts

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Matthias Carlebach, MD

Role: primary

[email protected]
+ 972-4-8359426

Alexandra Lavy, MD

Role: backup

[email protected]
+ 972-4-8359736

Other Identifiers

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Beta Carotene 01

Identifier Type: -

Identifier Source: org_study_id