Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT00275418
Status:
UNKNOWN
Last Update Posted:
2006-01-12
First Post:
2006-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Beta Carotene From Natural Source for Patients With Non-Active Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'lastUpdateSubmitDate': '2006-01-10', 'studyFirstSubmitDate': '2006-01-10', 'studyFirstSubmitQcDate': '2006-01-10', 'lastUpdatePostDateStruct': {'date': '2006-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CDAI score measured 3-monthly during treatment'}]}, 'conditionsModule': {'keywords': ["Crohn's disease", 'remission', 'beta carotene'], 'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "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.\n\nBeta carotene is an anti-oxidant vitamin present in many fruits and vegetables. The algae Dunaliella is particularly rich in beta carotene.\n\nIn this prospective trial we want to investigate whether beta carotene from Dunaliella may prevent exacerbations of Crohn's disease.", 'detailedDescription': "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.\n\nThe study medication will be taken in addition to regular treatment for Crohn's disease.\n\nThe 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.\n\nExacerbation 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with documented Crohn's disease in remission (CDAI\\<150) for at least two months, age 17-75 years\n\nExclusion Criteria:\n\n* active Crohn's disease (CDAI\\>150), partial bowel obstruction, impending surgery, pregnancy, serious other diseases"}, 'identificationModule': {'nctId': 'NCT00275418', 'briefTitle': "Beta Carotene From Natural Source for Patients With Non-Active Crohn's Disease", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': "Double-Blind Randomized Prospective Trial of Treatment With Natural Beta Carotene Vs. Placebo for Patients With Crohn's Disease in Remission", 'orgStudyIdInfo': {'id': 'Beta Carotene 01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'beta carotene from Dunaliella algae', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31048', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Matthias Carlebach, MD', 'role': 'CONTACT', 'email': 'matthias.carlebach@b-zion.org.il', 'phone': '+ 972-4-8359426'}, {'name': 'Alexandra Lavy, MD', 'role': 'CONTACT', 'email': 'lavya@netvision.net.il', 'phone': '+ 972-4-8359736'}, {'name': 'Matthias Carlebach, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Bnai Zion Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Matthias Carlebach, MD', 'role': 'CONTACT', 'email': 'matthias.carlebach@b-zion.org.il', 'phone': '+ 972-4-8359426'}, {'name': 'Alexandra Lavy, MD', 'role': 'CONTACT', 'email': 'lavya@netvision.net.il', 'phone': '+ 972-4-8359736'}], 'overallOfficials': [{'name': 'Alexandra Lavy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technion, Haifa, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}}}}