Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
Study NCT ID:
NCT00198666
Status:
COMPLETED
Last Update Posted:
2015-01-12
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Zinc in the Treatment of Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-09', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2015-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of severe symptoms', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Time to recovery from severe pneumonia', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pneumonia', 'zinc'], 'conditions': ['Pneumonia']}, 'referencesModule': {'references': [{'pmid': '17684211', 'type': 'DERIVED', 'citation': 'Coles CL, Bose A, Moses PD, Mathew L, Agarwal I, Mammen T, Santosham M. Infectious etiology modifies the treatment effect of zinc in severe pneumonia. Am J Clin Nutr. 2007 Aug;86(2):397-403. doi: 10.1093/ajcn/86.2.397.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the efficacy of zinc supplementation in the treatment of children under the age of two years who have been hospitalized with severe pneumonia.', 'detailedDescription': 'This study was a randomized, double-blind, placebo-controlled clinical trial conducted between September 2003 and August 2004 at the Christian Medical College (CMC) Hospital in Vellore, India. CMC Hospital is a large teaching hospital and medical center that is accessed directly by the population of Vellore and adjoining districts and by referrals from local medical practitioners.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children under two years old hospitalized with Pneumonia\n\nExclusion Criteria:\n\n* healthy children'}, 'identificationModule': {'nctId': 'NCT00198666', 'briefTitle': 'Efficacy of Zinc in the Treatment of Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Efficacy of Zinc in the Treatment of Pneumonia in Hospitalized Children Less Than 2 Years of Age', 'orgStudyIdInfo': {'id': 'H.22.03.01.06.A2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Children with severe pneumonia were randomly assigned to receive supplementation with elemental zinc.', 'interventionNames': ['Drug: Zinc']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Children with severe pneumonia were randomly assigned to receive supplementation with placebo tablets.'}], 'interventions': [{'name': 'Zinc', 'type': 'DRUG', 'description': 'Elemental Zinc', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mathuram Santosham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mathuram Santosham', 'investigatorAffiliation': 'Johns Hopkins Bloomberg School of Public Health'}}}}