Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT01571856
Status:
COMPLETED
Last Update Posted:
2013-05-07
First Post:
2012-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019287', 'term': 'Zinc Sulfate'}], 'ancestors': [{'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017967', 'term': 'Zinc Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-05', 'studyFirstSubmitDate': '2012-04-03', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'duration of diarrheal episode', 'timeFrame': 'five days', 'description': 'duration of diarreal episode, time in wich the watery stools will be normalized, an expected average of 5 days.'}], 'secondaryOutcomes': [{'measure': 'duration of hospitalization', 'timeFrame': '5 days', 'description': 'participants will be followed for the duration of hospital stay, an expected average of 5 days'}, {'measure': 'weight of stool', 'timeFrame': '5 days', 'description': 'we expected the weight of the stool will diminish by about 5 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Diarrhea', 'Zinc', 'Children'], 'conditions': ['Acute Diarrhea', 'Acute Gastroenteritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effect of zinc in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.', 'detailedDescription': 'Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, today exist strong evidence of beneficial effect of use of zinc in acute diarrhea in children over 6 months. but there are not enough clinical trials to show this beneficial effect on children under 6 months.\n\nObjectives: To evaluate the effect of zinc in the treatment of children under 6 months age with acute diarrhea.\n\nMethods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive zinc plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of diarrhea stools by day, weight of stool, nutritional state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all acute diarrhea\n\nExclusion Criteria:\n\n* Severe malnourishment\n* Severe dehydration\n* Systemic infections\n* coinfections'}, 'identificationModule': {'nctId': 'NCT01571856', 'briefTitle': 'Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Centro Pediatrico Albina de Patino'}, 'officialTitle': 'Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants Under Six Months.', 'orgStudyIdInfo': {'id': 'protzinc2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'zinc sulfate', 'description': 'zinc sulphate solution.', 'interventionNames': ['Drug: Zinc Sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'cornstarch solution', 'description': 'cornstarch powder diluted in distilled water', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Zinc Sulfate', 'type': 'DRUG', 'otherNames': ['Suplizinc'], 'description': 'zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.', 'armGroupLabels': ['zinc sulfate']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'cornstarch powder diluted in distilled water, dosage 2.5 ml per day', 'armGroupLabels': ['cornstarch solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cochabamba', 'state': 'Departamento de Cochabamba', 'country': 'Bolivia', 'facility': 'Centro Pediatrico Albina Patino', 'geoPoint': {'lat': -17.38195, 'lon': -66.15995}}], 'overallOfficials': [{'name': 'Giuseppe Grandy, MD MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro Pediatrico Albina de Patino'}, {'name': 'Zaida Cama, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centro Pediatrico Albina Ptino'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Pediatrico Albina de Patino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Chief of Nutrition Center', 'investigatorFullName': 'Giuseppe Grandy', 'investigatorAffiliation': 'Centro Pediatrico Albina de Patino'}}}}