Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 10:06 PM
Study NCT ID:
NCT00841061
Status:
COMPLETED
Last Update Posted:
2009-02-11
First Post:
2009-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cereals as a Source of Iron for Breastfed Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C031621', 'term': 'ferrous fumarate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-09', 'studyFirstSubmitDate': '2009-02-09', 'studyFirstSubmitQcDate': '2009-02-09', 'lastUpdatePostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'plasma ferritin', 'timeFrame': '280 days'}], 'secondaryOutcomes': [{'measure': 'hemoglobin', 'timeFrame': '280'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Iron Deficiency']}, '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.'}]}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '28 Days', 'healthyVolunteers': True, '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'}, 'identificationModule': {'nctId': 'NCT00841061', 'acronym': 'Bfe03B', 'briefTitle': 'Cereals as a Source of Iron for Breastfed Infants', 'organization': {'class': 'NIH', 'fullName': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, 'officialTitle': 'Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron', 'orgStudyIdInfo': {'id': 'B530500'}, 'secondaryIdInfos': [{'id': 'HD40315-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cereal L', 'description': 'Rice cereal with electrolytic iron', 'interventionNames': ['Dietary Supplement: electrolytic iron']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cereal M', 'description': 'Rice cereal with ferrous fumarate', 'interventionNames': ['Dietary Supplement: ferrous fumarate']}], 'interventions': [{'name': 'electrolytic iron', 'type': 'DIETARY_SUPPLEMENT', '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']}, {'name': 'ferrous fumarate', 'type': 'DIETARY_SUPPLEMENT', '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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Ekhard E Ziegler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Dr. Ekhard E. Ziegler', 'oldOrganization': 'University of Iowa'}}}}