Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-28 @ 3:36 AM
Study NCT ID:
NCT00392561
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2006-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bangladesh Vitamin E and Selenium Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012643', 'term': 'Selenium'}, {'id': 'D014810', 'term': 'Vitamin E'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2006-10-24', 'studyFirstSubmitQcDate': '2006-10-24', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Cancer', 'timeFrame': 'Incidence during the 6-year study period'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Occurrence during the 6-year study period'}, {'measure': 'Diabetes', 'timeFrame': 'Incidence within 6-year study period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-melanoma Skin Cancer']}, 'referencesModule': {'references': [{'pmid': '39851523', 'type': 'DERIVED', 'citation': 'Jasmine F, Almazan A, Khamkevych Y, Argos M, Shahriar M, Islam T, Shea CR, Ahsan H, Kibriya MG. Gene-Environment Interaction: Small Deletions (DELs) and Transcriptomic Profiles in Non-Melanoma Skin Cancer (NMSC) and Potential Implications for Therapy. Cells. 2025 Jan 10;14(2):95. doi: 10.3390/cells14020095.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether selenium and/or vitamin E are effective in preventing non-melanoma skin cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Manifest arsenic skin lesions (melanosis, leucomelanosis, or keratosis)\n* Aged 25 to 65 years\n* Permanent resident of study area\n\nExclusion Criteria:\n\n* Pregnancy\n* Clinically too ill (enlarged spleen or liver)\n* Presence of gangrene\n* Cancer'}, 'identificationModule': {'nctId': 'NCT00392561', 'acronym': 'BEST', 'briefTitle': 'Bangladesh Vitamin E and Selenium Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Bangladesh Vitamin E and Selenium Trial', 'orgStudyIdInfo': {'id': '15091A (R01-CA10743-1)'}, 'secondaryIdInfos': [{'id': 'AAAB2309', 'type': 'OTHER', 'domain': 'CUMC IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Selenium', 'interventionNames': ['Dietary Supplement: Selenium']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Vitamin E', 'interventionNames': ['Dietary Supplement: vitamin E']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Vitamin E + Selenium', 'interventionNames': ['Dietary Supplement: Selenium', 'Dietary Supplement: vitamin E']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 4'}], 'interventions': [{'name': 'Selenium', 'type': 'DIETARY_SUPPLEMENT', 'description': '200 ug Selenium daily', 'armGroupLabels': ['1', '3']}, {'name': 'vitamin E', 'type': 'DIETARY_SUPPLEMENT', 'description': '100 mg Vitamin E daily', 'armGroupLabels': ['2', '3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'Columbia University Arsenic Research Project', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}, {'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'ICDDR,B', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Habibul Ahsan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'Columbia University', 'class': 'OTHER'}, {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, {'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}