Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 3:41 AM
Study NCT ID:
NCT00303160
Status:
UNKNOWN
Last Update Posted:
2007-08-14
First Post:
2006-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Helicobacter Pylori on the Availability of Vitamin E and C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2007-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-08-13', 'studyFirstSubmitDate': '2006-03-14', 'studyFirstSubmitQcDate': '2006-03-14', 'lastUpdatePostDateStruct': {'date': '2007-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma vitamin C levels'}, {'measure': 'plasma vitamin E levels'}], 'secondaryOutcomes': [{'measure': 'TBARS levels'}]}, 'conditionsModule': {'keywords': ['heliobacter pylori infection', 'reactive oxygen species', 'antioxidants'], 'conditions': ['Heliobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'This study argues that H.pylori infection, by increasing the production of reactive oxygen species, increases the utilization of dietary antioxidants(Vit E and Vit C) that serve in quenching the free radicals, thus decreasing their serum levels and confounding their protective effect against gastric cancer.', 'detailedDescription': 'It has been postulated that dietary antioxidants may reduce cancer risk by modulating red-ox status, by preventing biological oxidation, and by inhibiting the formation of carcinogen. However, supplementation studies and prospective studies have yielded contradictory results. In the case of gastric cancer, H.pylori infection, which is known to be associated with a higher risk of the disease, results in an increased production of ROS \\& RNS. As a result serum levels of these free radicals increase, exerting a higher demand for dietary antioxidants to neutralize them.\n\nThe fact that the relation between serum levels of antioxidants and gastric cancer is more consistent than that of dietary intake levels and the disease suggests the possibility of the presence of an intrinsic factor that is altering the true relation between dietary antioxidants and the cancer. This intrinsic factor, this study argues, is the infection with H.pylori.\n\nH.pylori infection, by increasing the production of reactive oxygen species, increases the utilization of dietary antioxidants that serve in quenching the free radicals, thus decreasing their serum levels and confounding their protective effect against gastric cancer. The purpose of this pilot study is to investigate the possibility that H.pylori infection alters the bioavailability of the dietary antioxidants: vitamin C, and vitamin E. This project will be done in preparation for an etiologic study of dietary antioxidants and gastric cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult , age 18-45\n\nExclusion Criteria:\n\n1. Smoking\n2. Body mass index below 18 or above 25.\n3. Previous treatment for H.pylori infection\n4. Partial or total gastrectomy\n5. History of gastritis\n6. Currently taking antioxidants supplementation\n7. Training in an athletic team.\n8. Drinking more than 3 servings of alcohol/day'}, 'identificationModule': {'nctId': 'NCT00303160', 'briefTitle': 'Effect of Helicobacter Pylori on the Availability of Vitamin E and C', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Effect of Helicobacter Pylori on the Availability of Vitamin E and C', 'orgStudyIdInfo': {'id': '15344'}}, 'armsInterventionsModule': {'interventions': [{'name': 'vitamin C & E supplements', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Farah Naja, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Canada: Cancer Care Ontario'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'CCERN: canadian cancer etiology research network', 'class': 'UNKNOWN'}]}}}