Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-28 @ 10:45 PM
Study NCT ID:
NCT00967551
Status:
COMPLETED
Last Update Posted:
2013-04-11
First Post:
2009-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Micronutrient Sprinkles in a Daycare Center
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hugocrj@ufba.br', 'title': 'Hugo Costa-Ribeiro', 'organization': 'Hospital Universitário Professor Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brasil'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Micronutrient Sprinkles Without Zinc', 'description': 'Micronutrient sprinkles without zinc\n\nMicronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc', 'otherNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Micronutrient Sprinkles With Zinc', 'description': 'Micronutrient sprinkles with zinc gluconate\n\nMicronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles', 'otherNumAtRisk': 75, 'otherNumAffected': 0, 'seriousNumAtRisk': 75, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Children of Diarrhea Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Micronutrient Sprinkles Without Zinc', 'description': 'Micronutrient sprinkles without zinc\n\nMicronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc'}, {'id': 'OG001', 'title': 'Micronutrient Sprinkles With Zinc', 'description': 'Micronutrient sprinkles with zinc gluconate\n\nMicronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of children with diarrhea divided by the number of children in the group', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All children enrolled'}, {'type': 'SECONDARY', 'title': 'Proportion of Children With Respiratory Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Micronutrient Sprinkles Without Zinc', 'description': 'Micronutrient sprinkles without zinc\n\nMicronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc'}, {'id': 'OG001', 'title': 'Micronutrient Sprinkles With Zinc', 'description': 'Micronutrient sprinkles with zinc gluconate\n\nMicronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles'}], 'classes': [{'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of children with respiratory infections divided by the total number of children in the group', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All children enrolled'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Micronutrient Sprinkles Without Zinc', 'description': 'Micronutrient sprinkles without zinc\n\nMicronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc'}, {'id': 'FG001', 'title': 'Micronutrient Sprinkles With Zinc', 'description': 'Micronutrient sprinkles with zinc gluconate\n\nMicronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy, 06 to 48 months old children attending a day care. They were randomized into two groups and received daily zinc micronutrient + - test group (sprinkles) or without zinc micronutrient only - control. Children were supplemented for 90 days'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Micronutrient Sprinkles Without Zinc', 'description': 'Micronutrient sprinkles without zinc\n\nMicronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc'}, {'id': 'BG001', 'title': 'Micronutrient Sprinkles With Zinc', 'description': 'Micronutrient sprinkles with zinc gluconate\n\nMicronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '2', 'groupId': 'BG000'}, {'value': '2.2', 'spread': '2', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-05', 'studyFirstSubmitDate': '2009-08-27', 'resultsFirstSubmitDate': '2013-01-24', 'studyFirstSubmitQcDate': '2009-08-27', 'lastUpdatePostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-01', 'studyFirstPostDateStruct': {'date': '2009-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Children of Diarrhea Episodes', 'timeFrame': '6 months', 'description': 'Number of children with diarrhea divided by the number of children in the group'}], 'secondaryOutcomes': [{'measure': 'Proportion of Children With Respiratory Infections', 'timeFrame': '6 months', 'description': 'Number of children with respiratory infections divided by the total number of children in the group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diarrhea', 'Pneumonia', 'Upper respiratory infections', 'Acute gastroenteritis'], 'conditions': ['Diarrhea', 'Respiratory Infection']}, 'referencesModule': {'references': [{'pmid': '36994923', 'type': 'DERIVED', 'citation': 'Imdad A, Rogner J, Sherwani RN, Sidhu J, Regan A, Haykal MR, Tsistinas O, Smith A, Chan XHS, Mayo-Wilson E, Bhutta ZA. Zinc supplementation for preventing mortality, morbidity, and growth failure in children aged 6 months to 12 years. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD009384. doi: 10.1002/14651858.CD009384.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Diarrheal diseases are a major cause of morbidity and mortality globally in children less than 5 years of age. Prolonged diarrhea, recurrent infections and growth failure in developing countries are usually a consequence of micronutrient deficiencies including zinc. The primary aims of the proposed study are to evaluate the effect of the use of multiple micronutrient sprinkles including zinc on compliance of supplement use and the incidence of recurrent diarrheal and respiratory illnesses. The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.', 'detailedDescription': 'The proposed study will be conducted at the Fima Lifshitz Metabolic Research Center, Department of Pediatrics, Universidade Federal Da Bahia, Salvador-Bahia, Brazil over a period of 18 months. This is a double-blind placebo-controlled trial involving the use of 2 types of micronutrient sprinkles in a group of 120 children who attend a day care center in Salvador, Bahia. They will be randomized into 2 groups of 60 children each. The intervention group will receive sprinkles containing zinc while the control group will receive micronutrient sprinkles without zinc. The primary outcome variables of interest are zinc status, stool zinc losses and diarrhea duration. Both groups of infants will be monitored at monthly intervals for an initial duration of 180 days for zinc status, diarrhea episodes, respiratory illness and growth. This study will allow for the establishment of a cohort of children who will be monitored in a micronutrient supplementation trial using sprinkles.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy children attending day care\n\nExclusion Criteria:\n\n* Chronic medical problems including sickle cell disease, congenital heart disease'}, 'identificationModule': {'nctId': 'NCT00967551', 'briefTitle': 'Micronutrient Sprinkles in a Daycare Center', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'The Impact of the Use of Zinc Supplementation and Other Micronutrients on the Occurence of Diarrhea Diseases and Respiratory Infections in Children of Daycare Centers', 'orgStudyIdInfo': {'id': 'IRB00007903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Micronutrient Sprinkles without zinc', 'description': 'Micronutrient sprinkles without zinc', 'interventionNames': ['Dietary Supplement: Micronutrient sprinkles without zinc']}, {'type': 'EXPERIMENTAL', 'label': 'Micronutrient sprinkles with zinc', 'description': 'Micronutrient sprinkles with zinc gluconate', 'interventionNames': ['Dietary Supplement: Micronutrient Sprinkles with zinc']}], 'interventions': [{'name': 'Micronutrient Sprinkles with zinc', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Micronutrient sprinkles'], 'description': 'Daily dose of 1 packet of sprinkles', 'armGroupLabels': ['Micronutrient sprinkles with zinc']}, {'name': 'Micronutrient sprinkles without zinc', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Micronutrient sprinkles'], 'description': 'I packet of micronutrient sprinkles without zinc', 'armGroupLabels': ['Micronutrient Sprinkles without zinc']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Conrad R Cole, MD, MPH, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Hugo Ribeiro Da Costa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal da Bahia, Complexo Hospitalar Universitário Professor Edgar Santos, Centro de Pesquisa Fima Lifshitz, Salvador, Bahia, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federal University of Bahia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Conrad R. Cole', 'investigatorAffiliation': 'Emory University'}}}}