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{ | |
"protocolSection": { | |
"identificationModule": { | |
"nctId": "NCT00841061", | |
"orgStudyIdInfo": { | |
"id": "B530500" | |
}, | |
"secondaryIdInfos": [ | |
{ | |
"id": "HD40315-01" | |
} | |
], | |
"organization": { | |
"fullName": "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)", | |
"class": "NIH" | |
}, | |
"briefTitle": "Cereals as a Source of Iron for Breastfed Infants", | |
"officialTitle": "Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron", | |
"acronym": "Bfe03B" | |
}, | |
"statusModule": { | |
"statusVerifiedDate": "2009-01", | |
"overallStatus": "COMPLETED", | |
"expandedAccessInfo": { | |
"hasExpandedAccess": false | |
}, | |
"startDateStruct": { | |
"date": "2003-07" | |
}, | |
"primaryCompletionDateStruct": { | |
"date": "2006-05", | |
"type": "ACTUAL" | |
}, | |
"completionDateStruct": { | |
"date": "2006-05", | |
"type": "ACTUAL" | |
}, | |
"studyFirstSubmitDate": "2009-02-09", | |
"studyFirstSubmitQcDate": "2009-02-09", | |
"studyFirstPostDateStruct": { | |
"date": "2009-02-11", | |
"type": "ESTIMATED" | |
}, | |
"lastUpdateSubmitDate": "2009-02-09", | |
"lastUpdatePostDateStruct": { | |
"date": "2009-02-11", | |
"type": "ESTIMATED" | |
} | |
}, | |
"sponsorCollaboratorsModule": { | |
"responsibleParty": { | |
"oldNameTitle": "Dr. Ekhard E. Ziegler", | |
"oldOrganization": "University of Iowa" | |
}, | |
"leadSponsor": { | |
"name": "National Institutes of Health (NIH)", | |
"class": "NIH" | |
} | |
}, | |
"oversightModule": { | |
"oversightHasDmc": false | |
}, | |
"descriptionModule": { | |
"briefSummary": "The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency." | |
}, | |
"conditionsModule": { | |
"conditions": [ | |
"Iron Deficiency" | |
] | |
}, | |
"designModule": { | |
"studyType": "INTERVENTIONAL", | |
"phases": [ | |
"NA" | |
], | |
"designInfo": { | |
"allocation": "RANDOMIZED", | |
"interventionModel": "PARALLEL", | |
"primaryPurpose": "PREVENTION", | |
"maskingInfo": { | |
"masking": "QUADRUPLE", | |
"whoMasked": [ | |
"PARTICIPANT", | |
"CARE_PROVIDER", | |
"INVESTIGATOR", | |
"OUTCOMES_ASSESSOR" | |
] | |
} | |
}, | |
"enrollmentInfo": { | |
"count": 111, | |
"type": "ACTUAL" | |
} | |
}, | |
"armsInterventionsModule": { | |
"armGroups": [ | |
{ | |
"label": "Cereal L", | |
"type": "ACTIVE_COMPARATOR", | |
"description": "Rice cereal with electrolytic iron", | |
"interventionNames": [ | |
"Dietary Supplement: electrolytic iron" | |
] | |
}, | |
{ | |
"label": "Cereal M", | |
"type": "ACTIVE_COMPARATOR", | |
"description": "Rice cereal with ferrous fumarate", | |
"interventionNames": [ | |
"Dietary Supplement: ferrous fumarate" | |
] | |
} | |
], | |
"interventions": [ | |
{ | |
"type": "DIETARY_SUPPLEMENT", | |
"name": "electrolytic iron", | |
"description": "1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age", | |
"armGroupLabels": [ | |
"Cereal L" | |
] | |
}, | |
{ | |
"type": "DIETARY_SUPPLEMENT", | |
"name": "ferrous fumarate", | |
"description": "1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age", | |
"armGroupLabels": [ | |
"Cereal M" | |
] | |
} | |
] | |
}, | |
"outcomesModule": { | |
"primaryOutcomes": [ | |
{ | |
"measure": "plasma ferritin", | |
"timeFrame": "280 days" | |
} | |
], | |
"secondaryOutcomes": [ | |
{ | |
"measure": "hemoglobin", | |
"timeFrame": "280" | |
} | |
] | |
}, | |
"eligibilityModule": { | |
"eligibilityCriteria": "Inclusion Criteria:\n\n* exclusively breastfed\n* birth weight between 2500 and 4200g\n* gestational age \\>36 weeks\n\nExclusion Criteria:\n\n* supplementing formula\n* no iron drops", | |
"healthyVolunteers": true, | |
"sex": "ALL", | |
"minimumAge": "28 Days", | |
"maximumAge": "1 Year", | |
"stdAges": [ | |
"CHILD" | |
] | |
}, | |
"contactsLocationsModule": { | |
"overallOfficials": [ | |
{ | |
"name": "Ekhard E Ziegler, MD", | |
"affiliation": "University of Iowa", | |
"role": "PRINCIPAL_INVESTIGATOR" | |
} | |
], | |
"locations": [ | |
{ | |
"facility": "University of Iowa", | |
"city": "Iowa City", | |
"state": "Iowa", | |
"zip": "52242", | |
"country": "United States", | |
"geoPoint": { | |
"lat": 41.66113, | |
"lon": -91.53017 | |
} | |
} | |
] | |
}, | |
"referencesModule": { | |
"references": [ | |
{ | |
"pmid": "21178077", | |
"type": "DERIVED", | |
"citation": "Ziegler EE, Fomon SJ, Nelson SE, Jeter JM, Theuer RC. Dry cereals fortified with electrolytic iron or ferrous fumarate are equally effective in breast-fed infants. J Nutr. 2011 Feb;141(2):243-8. doi: 10.3945/jn.110.127266. Epub 2010 Dec 22." | |
} | |
] | |
} | |
}, | |
"derivedSection": { | |
"miscInfoModule": { | |
"versionHolder": "2024-05-03" | |
}, | |
"conditionBrowseModule": { | |
"meshes": [ | |
{ | |
"id": "D000090463", | |
"term": "Iron Deficiencies" | |
} | |
], | |
"ancestors": [ | |
{ | |
"id": "D000019189", | |
"term": "Iron Metabolism Disorders" | |
}, | |
{ | |
"id": "D000008659", | |
"term": "Metabolic Diseases" | |
} | |
], | |
"browseLeaves": [ | |
{ | |
"id": "M20857", | |
"name": "Anemia, Iron-Deficiency", | |
"relevance": "LOW" | |
}, | |
{ | |
"id": "M2781", | |
"name": "Iron Deficiencies", | |
"asFound": "Iron Deficiency", | |
"relevance": "HIGH" | |
}, | |
{ | |
"id": "M11639", | |
"name": "Metabolic Diseases", | |
"relevance": "LOW" | |
}, | |
{ | |
"id": "M21177", | |
"name": "Iron Metabolism Disorders", | |
"relevance": "LOW" | |
} | |
], | |
"browseBranches": [ | |
{ | |
"abbrev": "BC15", | |
"name": "Blood and Lymph Conditions" | |
}, | |
{ | |
"abbrev": "BC18", | |
"name": "Nutritional and Metabolic Diseases" | |
}, | |
{ | |
"abbrev": "All", | |
"name": "All Conditions" | |
} | |
] | |
}, | |
"interventionBrowseModule": { | |
"meshes": [ | |
{ | |
"id": "C000031621", | |
"term": "Ferrous fumarate" | |
} | |
], | |
"ancestors": [ | |
{ | |
"id": "D000014131", | |
"term": "Trace Elements" | |
}, | |
{ | |
"id": "D000018977", | |
"term": "Micronutrients" | |
}, | |
{ | |
"id": "D000045505", | |
"term": "Physiological Effects of Drugs" | |
} | |
], | |
"browseLeaves": [ | |
{ | |
"id": "M10533", | |
"name": "Iron", | |
"relevance": "LOW" | |
}, | |
{ | |
"id": "M225448", | |
"name": "Ferrous fumarate", | |
"asFound": "Mouse", | |
"relevance": "HIGH" | |
}, | |
{ | |
"id": "M21009", | |
"name": "Micronutrients", | |
"relevance": "LOW" | |
}, | |
{ | |
"id": "M16885", | |
"name": "Trace Elements", | |
"relevance": "LOW" | |
} | |
], | |
"browseBranches": [ | |
{ | |
"abbrev": "Micro", | |
"name": "Micronutrients" | |
}, | |
{ | |
"abbrev": "All", | |
"name": "All Drugs and Chemicals" | |
} | |
] | |
} | |
}, | |
"hasResults": false | |
} |