Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT01431469
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2011-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008892', 'term': 'Milk'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-05', 'studyFirstSubmitDate': '2011-08-31', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Episodes of acute respiratory infections and diarrheal disease', 'timeFrame': '28 weeks'}], 'secondaryOutcomes': [{'measure': 'Occurrence of allergic manifestations', 'timeFrame': '28 weeks'}, {'measure': 'Systemic antibiotic use', 'timeFrame': '28 weeks'}, {'measure': 'Duration of acute respiratory infection and diarrheal disease', 'timeFrame': '28 weeks'}, {'measure': 'Changes in stool patterns', 'timeFrame': '28 weeks'}, {'measure': 'Fecal and serum immune markers', 'timeFrame': '28 weeks'}, {'measure': 'Serum Ferritin and Zinc status', 'timeFrame': '28 weeks'}, {'measure': 'Incidence of stool parasites', 'timeFrame': '28 weeks'}, {'measure': 'Growth', 'timeFrame': '28 weeks'}, {'measure': 'Incidence of adverse events', 'timeFrame': '28 weeks', 'description': 'The incidence of any adverse event for each participant'}, {'measure': 'Acceptance of study product', 'timeFrame': '28 weeks', 'description': 'Acceptance of study product based on quantity consumed'}]}, 'conditionsModule': {'conditions': ['Acute Respiratory Infection', 'Diarrheal Disease']}, 'referencesModule': {'references': [{'pmid': '26920136', 'type': 'DERIVED', 'citation': "Pontes MV, Ribeiro TC, Ribeiro H, de Mattos AP, Almeida IR, Leal VM, Cabral GN, Stolz S, Zhuang W, Scalabrin DM. Cow's milk-based beverage consumption in 1- to 4-year-olds and allergic manifestations: an RCT. Nutr J. 2016 Feb 27;15:19. doi: 10.1186/s12937-016-0138-0."}]}, 'descriptionModule': {'briefSummary': 'The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child 12-48 months of age\n* Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization\n* Signed informed consent\n\nExclusion Criteria:\n\n* Child who is receiving predominantly breast-milk\n* Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization\n* Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child\n* Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization\n* Child's z-score of weight for length/height \\< -3 according to World Health Organization criteria"}, 'identificationModule': {'nctId': 'NCT01431469', 'briefTitle': 'Efficacy and Tolerance of a Follow-On Formula Fed to Children From 12-48 Months of Age in Salvador, Bahia, Brazil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'orgStudyIdInfo': {'id': '6001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': "Cow's Milk", 'description': "Powdered Whole Cow's Milk", 'interventionNames': ["Dietary Supplement: Cow's milk"]}, {'type': 'EXPERIMENTAL', 'label': 'Follow-On Formula', 'description': 'Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide', 'interventionNames': ['Dietary Supplement: Follow-On Formula']}], 'interventions': [{'name': "Cow's milk", 'type': 'DIETARY_SUPPLEMENT', 'description': "Powdered Whole Cow's Milk", 'armGroupLabels': ["Cow's Milk"]}, {'name': 'Follow-On Formula', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide', 'armGroupLabels': ['Follow-On Formula']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CEP 401 10-060', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Universidade Federal da Bahia, Hospital Universitário Prof. Edgard Santos Complexo HUPES, Centro Pediátrico Professor Hossanah Oliveira, Centro da Pesquisas Fima Lifshitz, Rua Augusto Viana s/n Canela', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Federal University of Bahia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}