Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-31 @ 9:09 AM
Study NCT ID:
NCT01444261
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2011-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Iron Deficiency in Breastfed Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020748', 'term': 'ferrous sulfate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2011-09-28', 'studyFirstSubmitQcDate': '2011-09-28', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Iron deficiency anemia will be prevented in all infants before 5.5 mo of age', 'timeFrame': '5.5 mo', 'description': 'Iron deficiency anemia will be defined as plasma ferritin less than 10 ug/L and hemoglobin less than 105 g/L. The expected outcome is there will be no infants with iron deficiency anemia before 5.5 mo of age.'}], 'secondaryOutcomes': [{'measure': 'Determine the number of infants with iron deficiency between 5.5 and 9 mo of age', 'timeFrame': '9 mo', 'description': 'Iron deficiency will be determined as plasma ferritin less than 10 ug/L. We will determine the number of infants with iron deficiency between 5.5 and 9 mo of age'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['iron deficiency', 'anemia'], 'conditions': ['Iron Deficiency', 'Anemia']}, 'descriptionModule': {'briefSummary': 'With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.', 'detailedDescription': 'Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Months', 'minimumAge': '4 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term infants\n* gestational age 37-42 weeks\n* birth weight \\> 2500 g\n* exclusively breastfed at 28 d of age\n* intend to breast feed until 9 mo of age\n\nExclusion Criteria:\n\n* supplemental formula before 4 mo of age'}, 'identificationModule': {'nctId': 'NCT01444261', 'briefTitle': 'Prevention of Iron Deficiency in Breastfed Infants', 'organization': {'class': 'NIH', 'fullName': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, 'officialTitle': 'Prevention of Iron Deficiency in Breastfed Infants', 'orgStudyIdInfo': {'id': 'BFe10D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Fer-in-Sol drops and iron-fortified cereal', 'interventionNames': ['Dietary Supplement: Fer-in-Sol']}, {'type': 'OTHER', 'label': 'Control', 'description': 'No intervention', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'Fer-in-Sol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Fer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal', 'armGroupLabels': ['Intervention']}, {'name': 'control', 'type': 'OTHER', 'description': 'No dietary supplements', 'armGroupLabels': ['Control']}]}, '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 Ziegler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of Iowa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ekhard Ziegler', 'investigatorAffiliation': 'University of Iowa'}}}}