Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT00446758
Status:
COMPLETED
Last Update Posted:
2012-09-14
First Post:
2007-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of Zinc and HIV Progression in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015032', 'term': 'Zinc'}], 'ancestors': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-13', 'studyFirstSubmitDate': '2007-03-12', 'studyFirstSubmitQcDate': '2007-03-12', 'lastUpdatePostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbidity from respiratory and diarrheal infections, HIV disease progression', 'timeFrame': 'every 4 to 6 months until the end of follow-up'}], 'secondaryOutcomes': [{'measure': 'growth in height and weight', 'timeFrame': 'every 4 to 6 months until the end of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Zinc', 'HIV', 'Infants', 'Children', 'Morbidity', 'Child health outcomes', 'treatment naive', 'treatment experienced'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'To examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth.', 'detailedDescription': 'The purpose of this study is to examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '6 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV Infected Children under 60 months of age presenting at HIV treatment clinics in Dar es Salaam, Tanzania\n\nExclusion Criteria:\n\nEligible for ART: CD4 cell counts \\< 20% or above pediatric clinical stage of HIV disease 3 according to WHO staging system.\n\nSevere acute malnutrition; Major congenital malformations'}, 'identificationModule': {'nctId': 'NCT00446758', 'briefTitle': 'Trial of Zinc and HIV Progression in Children', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Trial of Zinc and HIV Progression in Children', 'orgStudyIdInfo': {'id': '14511'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zinc', 'description': 'zinc (as zinc sulphate) 12.5 mg orally per day (6.25 mg in children \\< 12 mo)', 'interventionNames': ['Dietary Supplement: Zinc']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Zinc']}], 'interventions': [{'name': 'Zinc', 'type': 'DIETARY_SUPPLEMENT', 'description': 'zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children \\> 12 months.', 'armGroupLabels': ['Placebo', 'Zinc']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dar es Salaam', 'country': 'Tanzania', 'facility': 'Muhimbili University College of Health Sciences', 'geoPoint': {'lat': -6.82349, 'lon': 39.26951}}], 'overallOfficials': [{'name': 'Eduardo Villamor, MD, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Thrasher Research Fund', 'class': 'OTHER'}, {'name': 'Muhimbili University of Health and Allied Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Associate Professor of International Nutrition', 'investigatorFullName': 'Eduardo Villamor', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}