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

  • STATUS
    Recruiting
  • participants needed
    300
  • sponsor
    Bnai Zion Medical Center
Updated on 22 January 2022
remission
vitamin
crohn's disease in remission

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.

Details
Condition Crohn's Disease
Treatment beta carotene from Dunaliella algae
Clinical Study IdentifierNCT00275418
SponsorBnai Zion Medical Center
Last Modified on22 January 2022

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