Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT00716105
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2008-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Level of Dietary Protein on Infant Growth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041943', 'term': 'Infant Formula'}], 'ancestors': [{'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D007225', 'term': 'Infant 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']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-18', 'studyFirstSubmitDate': '2008-07-11', 'studyFirstSubmitQcDate': '2008-07-15', 'lastUpdatePostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean weight gain', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infant formula', 'Protein metabolism'], 'conditions': ['Infant Nutrition']}, 'referencesModule': {'references': [{'pmid': '26154030', 'type': 'DERIVED', 'citation': 'Ziegler EE, Fields DA, Chernausek SD, Steenhout P, Grathwohl D, Jeter JM, Nelson SE, Haschke F. Adequacy of Infant Formula With Protein Content of 1.6 g/100 kcal for Infants Between 3 and 12 Months. J Pediatr Gastroenterol Nutr. 2015 Nov;61(5):596-603. doi: 10.1097/MPG.0000000000000881.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Gestational age at least 37 weeks\n* Singleton birth\n* Birth weight between 2500g and 4500g\n* Weight at enrolment is at or above the 5th percentile (CDC)\n* Infant has been exclusively formula fed for at least the last 14 days\n* Having obtained informed consent of legal representative\n\nExclusion Criteria:\n\n* Congenital illness or malformation that affects infant feeding and/or growth\n* Significant pre-natal and/or post-natal disease\n* Suspected or confirmed allergy to cow milk protein\n* In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)\n* Currently participating in another clinical trial"}, 'identificationModule': {'nctId': 'NCT00716105', 'briefTitle': 'Effect of the Level of Dietary Protein on Infant Growth', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life', 'orgStudyIdInfo': {'id': '06.29.INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Standard Infant Formula', 'interventionNames': ['Other: Standard infant formula']}, {'type': 'EXPERIMENTAL', 'label': 'Test Product', 'description': 'Infant formula with different level of proteins', 'interventionNames': ['Other: Infant formula with different level of proteins']}, {'type': 'NO_INTERVENTION', 'label': 'Breast Milk', 'description': 'Breastfeeding reference group'}], 'interventions': [{'name': 'Standard infant formula', 'type': 'OTHER', 'description': 'From 3 to 12 months of age. As per standard requirement', 'armGroupLabels': ['Control']}, {'name': 'Infant formula with different level of proteins', 'type': 'OTHER', 'description': 'From 3 to 12 months of age. As per standard requirement', 'armGroupLabels': ['Test Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '73102', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Department of Pediatrics University of Oklahoma Health Sciences', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Ekhard E Ziegler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Samuel J. Fomon Infant Nutrition Unit Dept of Pediatrics, University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}