Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-17 @ 9:54 PM
Study NCT ID:
NCT02253095
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2014-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Package of Interventions for Environmental Enteropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015766', 'term': 'Albendazole'}, {'id': 'D015032', 'term': 'Zinc'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-02', 'studyFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dual Sugar Absorption Test', 'timeFrame': '12 weeks', 'description': 'lactulose-mannitol ratio in urine'}, {'measure': 'Dual Sugar Absorption Test', 'timeFrame': '24 weeks', 'description': 'lactulose-mannitol ratio in urine'}], 'secondaryOutcomes': [{'measure': 'Lactulose Excretion', 'timeFrame': '12 weeks', 'description': 'percentage of ingested lactulose excreted in urine'}, {'measure': 'Lactulose Excretion', 'timeFrame': '24 weeks', 'description': 'percentage of ingested lactulose excreted in urine'}, {'measure': 'Mannitol Excretion', 'timeFrame': '12 weeks', 'description': 'percentage of ingested mannitol excreted in urine'}, {'measure': 'Mannitol Excretion', 'timeFrame': '24 weeks', 'description': 'percentage of ingested mannitol excreted in urine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Environmental Enteropathy']}, 'referencesModule': {'references': [{'pmid': '27807040', 'type': 'DERIVED', 'citation': 'Wang AZ, Shulman RJ, Crocker AH, Thakwalakwa C, Maleta KM, Devaraj S, Manary MJ, Trehan I. A Combined Intervention of Zinc, Multiple Micronutrients, and Albendazole Does Not Ameliorate Environmental Enteric Dysfunction or Stunting in Rural Malawian Children in a Double-Blind Randomized Controlled Trial. J Nutr. 2017 Jan;147(1):97-103. doi: 10.3945/jn.116.237735. Epub 2016 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '35 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children residing in catchment area of Limela, Machinga District, Malawi\n* aged 12-35 months\n* youngest eligible child in each household\n\nExclusion Criteria:\n\n* severe acute malnutrition\n* severe chronic illness\n* children unable to drink 20 mL of dual sugar solution\n* children in need of acute medical treatment for illness or injury at time of enrollment'}, 'identificationModule': {'nctId': 'NCT02253095', 'briefTitle': 'Combined Package of Interventions for Environmental Enteropathy', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Randomized, Double Blind, Placebo Controlled Trial Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children', 'orgStudyIdInfo': {'id': 'EE-zinc-alb-micronut'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multiple Intervention Arm', 'description': 'single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients', 'interventionNames': ['Drug: Albendazole', 'Dietary Supplement: Zinc', 'Dietary Supplement: Multiple Micronutrient Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'three placebos', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Albendazole', 'type': 'DRUG', 'armGroupLabels': ['Multiple Intervention Arm']}, {'name': 'Zinc', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Multiple Intervention Arm']}, {'name': 'Multiple Micronutrient Supplement', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Multiple Intervention Arm']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Limela', 'state': 'Machinga Distric', 'country': 'Malawi', 'facility': 'Limela Rural Site', 'geoPoint': {'lat': -14.88333, 'lon': 34.71667}}], 'overallOfficials': [{'name': 'Mark J Manary, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University in St. Louis; University of Malawi'}, {'name': 'Chrissie Thakwalakwa, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Malawi'}, {'name': 'Indi Trehan, MD MPH DTM&H', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Washington University in St. Louis; University of Malawi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Malawi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}