{
    "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
}