Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-25 @ 8:31 PM
Study NCT ID:
NCT02776592
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-14', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-05-17', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Working Memory Capacity', 'timeFrame': 'Up to 24 weeks', 'description': 'Recall of variable sequences'}], 'secondaryOutcomes': [{'measure': 'Change in Motor Response Speeds', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Change in Mental Response Speeds', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Change in Retention of Visual Information', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Change in Manipulation of Visual Information', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Change in Child Behavior Checklist', 'timeFrame': 'Up to 24 weeks', 'description': 'Assessment of adaptive function'}, {'measure': 'Stool Consistency Assessment', 'timeFrame': '24 weeks'}, {'measure': 'Systemic antibiotic Usage', 'timeFrame': '24 weeks'}, {'measure': 'Missed days due to illness', 'timeFrame': '24 weeks'}, {'measure': 'Body Weight', 'timeFrame': '24 weeks'}, {'measure': 'Height', 'timeFrame': '24 weeks'}, {'measure': 'Study Product Intake Assessment', 'timeFrame': '24 weeks'}, {'measure': 'Complete Blood Count (CBC)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Blood Fatty Acids', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Metabolite Biomarkers', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Serum Phospholipids', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Immune Markers', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Medically-confirmed adverse events', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy Children'], 'conditions': ['Child Nutrition Sciences']}, 'descriptionModule': {'briefSummary': "This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age.", 'detailedDescription': "This study aims to determine if a cow's milk-based formula with added nutrients has an effect on memory, reaction time, strategy or other cognitive development indicators in children 4-5 years of age."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Health child, 4-5 years of age\n* Born as full-term (Gestational age of 37-42 weeks)\n* Consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to the baseline visit\n* Parents or legal guardian agrees not to feed child any food products or supplements containing probiotics or prebiotics\n* Signed informed consent\n\nExclusion Criteria:\n\n* History or known or suspected cow milk protein intolerance\n* Child who has received any food product ot supplement containing probiotics or prebiotics (with the exception of yogurt) in the 15 days prior to the baseline visit\n* Serious concurrent illness that will interfere in the general management of the child\n* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised\n* Child's z-score of weight for height at baseline is \\< -3 according to WHO criteria"}, 'identificationModule': {'nctId': 'NCT02776592', 'briefTitle': "Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children", 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': "Nutritive Effects of a Cow's Milk Based Formula Fed to Young Children", 'orgStudyIdInfo': {'id': '6036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': "A cow's milk-based formula with added nutrients", 'interventionNames': ["Other: Cow's milk-based formula with added nutrients"]}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': "A cow's milk-based formula", 'interventionNames': ["Other: Cow's milk-based formula"]}], 'interventions': [{'name': "Cow's milk-based formula with added nutrients", 'type': 'OTHER', 'armGroupLabels': ['Experimental']}, {'name': "Cow's milk-based formula", 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Research Center Fima Lifshitz - Federal University of Bahia', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Jon Vanderhoof, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mead Johnson Nutrition'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Federal University of Bahia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}