Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:46 PM
Study NCT ID:
NCT01488435
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2011-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age
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': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-05', 'studyFirstSubmitDate': '2011-12-05', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute respiratory infections and diarrheal disease', 'timeFrame': '28 weeks'}], 'secondaryOutcomes': [{'measure': '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': 'Baseline and 28 weeks'}, {'measure': 'Fecal immune markers', 'timeFrame': 'Baseline and 28 weeks'}, {'measure': 'Serum Ferritin status', 'timeFrame': 'Baseline and 28 weeks'}, {'measure': 'Incidence of stool parasites', 'timeFrame': 'Baseline and 28 weeks'}, {'measure': 'Growth', 'timeFrame': '28 weeks'}, {'measure': '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.'}, {'measure': 'Serum immune markers', 'timeFrame': 'Baseline and 28 weeks'}, {'measure': 'Serum zinc status', 'timeFrame': 'Baseline and 28 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Infection', 'Diarrheal Disease']}, 'referencesModule': {'references': [{'pmid': '24843061', 'type': 'DERIVED', 'citation': 'Li F, Jin X, Liu B, Zhuang W, Scalabrin D. Follow-up formula consumption in 3- to 4-year-olds and respiratory infections: an RCT. Pediatrics. 2014 Jun;133(6):e1533-40. doi: 10.1542/peds.2013-3598. Epub 2014 May 19.'}]}, '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': '36 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child 36-48 months of age\n* Child is currently attending a daycare and has attended for 6 months or less\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 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 height \\< -3 according to World Health Organization criteria"}, 'identificationModule': {'nctId': 'NCT01488435', 'briefTitle': 'Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'orgStudyIdInfo': {'id': '6012'}}, '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': '321000', 'city': 'Jinhua', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Shi-ji-xing Child Care Center, Jin Dong District', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}], 'overallOfficials': [{'name': 'Xingming Jin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Development and Behavioral Pediatrics, Shanghai Children Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Shanghai Children's Medical Center", 'class': 'OTHER'}, {'name': 'Shanghai, China', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}