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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
} |