Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-28 @ 6:56 AM
Study NCT ID:
NCT01470768
Status:
WITHDRAWN
Last Update Posted:
2012-03-22
First Post:
2011-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016269', 'term': 'Milk Hypersensitivity'}], 'ancestors': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Sponsor cancelled study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-20', 'studyFirstSubmitDate': '2011-10-26', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of fatty acids in whole blood of infants', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'body weight', 'timeFrame': '4 months'}, {'measure': 'Occurrence of allergic manifestations', 'timeFrame': '4 months'}, {'measure': 'Occurrence of adverse events', 'timeFrame': '4 months'}, {'measure': 'Incidence of gas', 'timeFrame': '4 months'}, {'measure': 'Incidence of fussiness', 'timeFrame': '4 months'}, {'measure': 'Stool characteristics', 'timeFrame': '4 months'}, {'measure': 'Body length', 'timeFrame': '4 months'}, {'measure': 'Head Circumference', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Cow's Milk Allergy", 'Intolerance to Extensively Hydrolyzed Formulas', 'Intolerance to Breast Milk']}, 'referencesModule': {'references': [{'pmid': '33006765', 'type': 'DERIVED', 'citation': 'Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial will compare the amount of fatty acids in whole blood of babies fed one of two study formulas for 4 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 0 to 6 months of age inclusive\n* Born at ≥ 37 weeks gestation\n* Birth weight of 2500 g (5 lb 8 oz) or more\n* Infants suspected to be cow's milk allergic and who do not tolerate extensively hydrolyzed formula OR infants intolerant to breast milk\n* Infants with symptoms suggestive of cow's milk allergy\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Infants who for whatever reasons were not discharged home as per routine\n* Infants with metabolic illness requiring a special formula\n* Infants fed with nasogastric tube"}, 'identificationModule': {'nctId': 'NCT01470768', 'briefTitle': 'Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based (AA) Formulas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'officialTitle': 'Evaluation of Fatty Acid Levels and Growth in Infants Fed Amino Acid Based Formulas', 'orgStudyIdInfo': {'id': '6005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1 - AA Formula with DHA and ARA', 'description': 'Marketed AA formula with Docosahexanoic Acid (DHA) and Arachidonic Acid (ARA)', 'interventionNames': ['Other: Amino Acid-based Formula with high DHA and ARA']}, {'type': 'OTHER', 'label': 'Arm 2 - AA Formula with alternative levels of DHA and ARA', 'interventionNames': ['Other: Amino Acid-based Formula with lower DHA and ARA']}], 'interventions': [{'name': 'Amino Acid-based Formula with high DHA and ARA', 'type': 'OTHER', 'armGroupLabels': ['Arm 1 - AA Formula with DHA and ARA']}, {'name': 'Amino Acid-based Formula with lower DHA and ARA', 'type': 'OTHER', 'armGroupLabels': ['Arm 2 - AA Formula with alternative levels of DHA and ARA']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1N1EH', 'city': 'London', 'state': 'United Kingdon', 'country': 'United Kingdom', 'facility': 'Great Ormand Street Hospital and Institute of Child Health', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nikhil Thapar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCL Institute of Child Health and Great Ormond Street Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}