Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-05 @ 10:58 PM
Study NCT ID:
NCT01743066
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2012-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin E Level in Buccal Cells of Arsenicosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014810', 'term': 'Vitamin E'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2012-12-01', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the amount of vitamin E in buccal cells', 'timeFrame': '0 week (baseline), 20 weeks (end)', 'description': 'Changes in the amount of vitamin E in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.'}], 'secondaryOutcomes': [{'measure': 'Changes in the amount of cholesterol in buccal cells', 'timeFrame': '0 week (baseline), 20 weeks (end)', 'description': 'Changes in the amount of cholesterol in buccal cells of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.'}, {'measure': 'Changes in the concentration of vitamin E in serum', 'timeFrame': '0 week (baseline), 20 weeks (end)', 'description': 'Changes in the concentration of vitamin E in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.'}, {'measure': 'Changes in the concentration of cholesterol in serum', 'timeFrame': '0 week (baseline), 20 weeks (end)', 'description': 'Changes in the concentration of cholesterol in serum of arsenicosis patients, arsenic exposed controls and healthy volunteers will be estimated both before and after supplementation with vitamin E for 20 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Arsenic', 'Arsenicosis', 'Buccal cells', 'Serum', 'Vitamin E', 'Cholesterol'], 'conditions': ['Chronic Arsenic Poisoning']}, 'descriptionModule': {'briefSummary': 'To understand the pathogenesis of chronic arsenic toxicity, the investigators need to know the levels of vitamin E in patients chronically exposed to high concentration of arsenic and if changes are found, what happens when supplemented with vitamin E. The buccal cells and serum of patients will be collected for the estimation of vitamin E both before and after supplementation with vitamin E. Similar samples will be collected from similar number of arsenic exposed controls and healthy volunteers for comparison.', 'detailedDescription': 'Chronic consumption of arsenic through water (drinking and cooking) and food leads to accumulation of arsenic within the cell. We usually give emphasis on the skin manifestations (melanosis and keratosis) of arsenicosis that is diagnosed first. Other manifestations remain un-diagnosed or diagnosed later. The severe form is the development of cancer in different organs mainly skin, lungs and urinary bladder. To understand the pathophysiology of the development of clinical manifestations appearing in the skin first, we need to understand interior of cells other than skin. One of the dietary supplements, vitamin E is found to be effective in improving the clinical signs/symptoms of melanosis and keratosis. Buccal cells are also exposed to arsenic and easy to collect. To understand the pathogenesis, we need to know the levels of vitamin E in patients of arsenicosis and if changes, what happens when supplemented with vitamin E. The buccal cells and serum of 20 patients will be collected for the estimation of vitamin E both before and after supplementation with vitamin E (200 IU, caplet) daily orally for 20 weeks. Similar samples will be collected from 20 arsenic exposed controls and 20 healthy volunteers for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor arsenicosis\n\n* who drank arsenic contaminated water (\\>50 µg/L) for more than 6 months\n* having physical signs of moderate degree of melanosis and keratosis\n\nFor arsenic exposed control\n\n* relative or family member of the patient\n* showing no physical signs of melanosis and keratosis\n* share same tube well water for drinking purpose for more than 6 months\n\nFor healthy volunteers\n\n* who drank arsenic safe water (\\<50 µg/L)\n* live in the same Upazilla\n* have no cutaneous manifestation\n* who voluntarily agree to participate\n\nExclusion Criteria:\n\n* tuberculosis, eczema psoriasis, contact dermatitis\n* patients getting treatment of arsenicosis\n* subject who voluntarily do not agree to participate'}, 'identificationModule': {'nctId': 'NCT01743066', 'briefTitle': 'Vitamin E Level in Buccal Cells of Arsenicosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': 'Vitamin E Level in Buccal Cells of Arsenicosis Patients Following Vitamin E Supplementation', 'orgStudyIdInfo': {'id': 'BSMMU-004-CT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arsenicosis patients', 'description': 'Vitamin E (200 IU, caplet) daily orally for 20 weeks', 'interventionNames': ['Dietary Supplement: Vitamin E']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arsenic exposed controls', 'description': 'vitamin E (200 IU, caplet) daily orally for 20 weeks', 'interventionNames': ['Dietary Supplement: Vitamin E']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heathy volunteers', 'description': 'Vitamin E (200 IU, caplet) daily orally for 20 weeks', 'interventionNames': ['Dietary Supplement: Vitamin E']}], 'interventions': [{'name': 'Vitamin E', 'type': 'DIETARY_SUPPLEMENT', 'description': 'vitamin E (200 IU, caplet) daily orally for 20 weeks', 'armGroupLabels': ['Arsenic exposed controls', 'Arsenicosis patients', 'Heathy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'Department of Pharmacology, Bangabandhu Sheikh Mujib Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. and Chairman', 'investigatorFullName': 'Prof. Mir Misbahuddin', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}