Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT01442727
Status:
COMPLETED
Last Update Posted:
2011-10-07
First Post:
2011-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Selenium in the Treatment of Arsenic Toxicity and Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020261', 'term': 'Arsenic Poisoning'}], 'ancestors': [{'id': 'D020260', 'term': 'Heavy Metal Poisoning, Nervous System'}, {'id': 'D020258', 'term': 'Neurotoxicity Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018038', 'term': 'Sodium Selenite'}, {'id': 'D012643', 'term': 'Selenium'}, {'id': 'D020887', 'term': 'Selenious Acid'}], 'ancestors': [{'id': 'D018036', 'term': 'Selenium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 819}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-06', 'studyFirstSubmitDate': '2011-09-22', 'studyFirstSubmitQcDate': '2011-09-27', 'lastUpdatePostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in arsenical melanosis', 'timeFrame': '0 weeks (baseline), 24 weeks, and 48 weeks (end)', 'description': "Arsenical melanosis was recorded in 4 quadrants of each patients' torsos using the Dermlite epiluminescence microscopy system. The images were then scored in a blinded, randomized fashion by a dermatologist."}], 'secondaryOutcomes': [{'measure': 'changes in blood arsenic levels', 'timeFrame': 'week 0, week 24 and week 48', 'description': "The levels of arsenic in patients' blood was measured to determine whether intervention had a differential effect."}, {'measure': 'changes in urinary arsenic levels', 'timeFrame': 'week 0, week 24 and week 48', 'description': "The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['arsenical melanosis', 'arsenical melanoses', 'arsenical keratosis', 'arsenical keratoses', 'arsenical cancer', 'arsenic cancers', 'arsenic', 'arsenicosis', 'arsenic exposure', 'arsenic toxicity', 'arsenic poisoning', 'drinking water', 'selenium', 'selenite', 'sodium selenite'], 'conditions': ['Arsenical Melanosis', 'Arsenical Keratosis', 'Arsenical Cancers', 'Arsenicosis', 'Arsenic Exposure', 'Arsenic Toxicity', 'Arsenic Poisoning']}, 'descriptionModule': {'briefSummary': 'Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. There are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a variety of animal models. The investigators have recently shown in animals and humans that this effect is mediated by the formation of \\[(GS)2AsSe\\]- , the seleno-bis(S-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two Phase II studies in China and Bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients.\n\nObjective: To assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. If proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident of Bangladesh in an arsenic-affected region (Chandpur)\n* Age between 12 and 55\n* Exposure to arsenic in home drinking water greater than 50 ug/L.\n* Arsenical melanosis on the torso confirmed by epiluminescence microscopy\n\nExclusion Criteria:\n\n* Recent history or plans to consume selenium-containing supplements\n* Anticipated change in home drinking water supply during study period'}, 'identificationModule': {'nctId': 'NCT01442727', 'acronym': 'SETAC', 'briefTitle': 'Selenium in the Treatment of Arsenic Toxicity and Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Texas Tech University'}, 'officialTitle': 'Selenite in the Detoxification of Arsenic and the Prevention of Arsenical Melanosis and Cancers Amongst Bangladeshi Arsenicosis Patients: A 48-week, Randomized, Double-blinded, Placebo-controlled Phase III Trial', 'orgStudyIdInfo': {'id': 'TTU-JES-1'}, 'secondaryIdInfos': [{'id': '1R21CA117111-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21CA117111-01', 'type': 'NIH'}, {'id': 'ROG-06-098-01', 'type': 'OTHER_GRANT', 'domain': 'The American Cancer Society'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients who receive control (placebo)', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Selenium', 'description': 'Patients who receive treatment (selenium)', 'interventionNames': ['Drug: sodium selenite']}], 'interventions': [{'name': 'sodium selenite', 'type': 'DRUG', 'otherNames': ['selenium', 'selenite'], 'description': '200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.', 'armGroupLabels': ['Selenium']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kalibari Town', 'state': 'Chandpur District', 'country': 'Bangladesh', 'facility': 'SETAC Trial Field Office'}], 'overallOfficials': [{'name': 'Julian E Spallholz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas Tech University'}, {'name': 'Paul F La Porte, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pritzker School of Medicine, The University of Chicago'}, {'name': 'Selim Ahmed, MBBS, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Child & Mother Health, Dhaka, Bangladesh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas Tech University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition & Biochemistry, Division of Nutritional Sciences, College of Human Sciences, Texas Tech University.', 'investigatorFullName': 'Julian Spallholz', 'investigatorAffiliation': 'Texas Tech University'}}}}