Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT01166451
Status:
COMPLETED
Last Update Posted:
2011-10-18
First Post:
2010-07-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Anemia Control Program: High or Low Iron Supplementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 835}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-17', 'studyFirstSubmitDate': '2010-07-19', 'studyFirstSubmitQcDate': '2010-07-19', 'lastUpdatePostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1994-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Iron deficiency anemia', 'timeFrame': '12 and 18 months'}], 'secondaryOutcomes': [{'measure': 'Longitudinal child behavior and development', 'timeFrame': '10 years'}]}, 'conditionsModule': {'keywords': ['iron deficiency anemia', 'cognitive development', 'motor development'], 'conditions': ['Iron Deficiency Anemia', 'Cognitive Development', 'Motor Development']}, 'referencesModule': {'references': [{'pmid': '9580762', 'type': 'RESULT', 'citation': 'Walter T, Pino P, Pizarro F, Lozoff B. Prevention of iron-deficiency anemia: comparison of high- and low-iron formulas in term healthy infants after six months of life. J Pediatr. 1998 Apr;132(4):635-40. doi: 10.1016/s0022-3476(98)70352-x.'}, {'pmid': '34927561', 'type': 'DERIVED', 'citation': 'East PL, Reid B, Blanco E, Burrows R, Lozoff B, Gahagan S. Iron supplementation given to nonanemic infants: neurocognitive functioning at 16 years. Nutr Neurosci. 2023 Jan;26(1):40-49. doi: 10.1080/1028415X.2021.2013399. Epub 2021 Dec 19.'}, {'pmid': '32778008', 'type': 'DERIVED', 'citation': 'East P, Doom J, Blanco E, Burrows R, Lozoff B, Gahagan S. Young adult outcomes associated with lower cognitive functioning in childhood related to iron-fortified formula in infancy. Nutr Neurosci. 2022 Apr;25(4):709-718. doi: 10.1080/1028415X.2020.1804099. Epub 2020 Aug 11.'}, {'pmid': '31253407', 'type': 'DERIVED', 'citation': 'Gahagan S, Delker E, Blanco E, Burrows R, Lozoff B. Randomized Controlled Trial of Iron-Fortified versus Low-Iron Infant Formula: Developmental Outcomes at 16 Years. J Pediatr. 2019 Sep;212:124-130.e1. doi: 10.1016/j.jpeds.2019.05.030. Epub 2019 Jun 26.'}, {'pmid': '22064877', 'type': 'DERIVED', 'citation': 'Lozoff B, Castillo M, Clark KM, Smith JB. Iron-fortified vs low-iron infant formula: developmental outcome at 10 years. Arch Pediatr Adolesc Med. 2012 Mar;166(3):208-15. doi: 10.1001/archpediatrics.2011.197. Epub 2011 Nov 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial was to determine if high-iron or low-iron formula, containing an average of 12.7 mg/L or 2.3 mg/L respectively, had differing effects on iron status in infancy and on development longitudinally.', 'detailedDescription': 'For a detailed description of the clinical trial setting and procedures in infancy, please refer to the following:\n\nWalter T, Pino P, Pizarro F and Lozoff B. Prevention of iron-deficiency anemia: Comparison of high- and low-iron formulas in term healthy infants after six months of life. J Pedr 1998:132:635-40.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight \\>= 3.0 kg\n* single birth\n* no major congenital anomalies\n* no major birth or neonatal complications\n* no emergency c-section\n* no jaundice requiring phototherapy\n* no hospitalization for more than 5 days\n* no chronic illness\n* no iron therapy\n* already started to received some bottle feedings by 6 months of age\n\nExclusion Criteria:\n\n* residence outside identified neighborhoods\n* another infant \\<12 months in household\n* infant in daycare\n* unstable, illiterate, or psychotic caregiver'}, 'identificationModule': {'nctId': 'NCT01166451', 'briefTitle': 'The Anemia Control Program: High or Low Iron Supplementation', 'organization': {'class': 'NIH', 'fullName': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, 'officialTitle': 'Iron Deficiency Anemia and Infant Behavior: Preventive Trial', 'orgStudyIdInfo': {'id': 'R01HD033487', 'link': 'https://reporter.nih.gov/quickSearch/R01HD033487', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-iron', 'description': 'Infants randomly assigned at 6 months of age to receive low-iron formula (average 2.3 mg/L, range 1.6 - 2.4 mg/L) until 12 months of age.', 'interventionNames': ['Dietary Supplement: Low-iron formula']}, {'type': 'EXPERIMENTAL', 'label': 'High-iron', 'description': 'Infants randomly assigned at 6 months of age to receive high-iron formula (average 12.7 mg/L) until 12 months of age.', 'interventionNames': ['Dietary Supplement: High-iron formula']}], 'interventions': [{'name': 'Low-iron formula', 'type': 'DIETARY_SUPPLEMENT', 'description': "Infants randomly assigned at 6 months of age to receive low-iron formula (average 2.3 mg/L, range 1.6 - 2.4 mg/L) until 12 months of age. Low-iron formula distributed in powdered form. Project personnel visited infants' homes weekly to record measures of powdered formula used per day. Formula consumption was also verified by the number of cans given by the clinic nurse at each visit (regular pediatric visits and monthly clinic appointments until 12 months of age.)", 'armGroupLabels': ['Low-iron']}, {'name': 'High-iron formula', 'type': 'DIETARY_SUPPLEMENT', 'description': "Infants randomly assigned at 6 months of age to receive high-iron formula (average 12.7 mg/L) until 12 months of age. High-iron formula distributed in powdered form. Project personnel visited infants' homes weekly to record measures of powdered formula used per day. Formula consumption was also verified by the number of cans given by the clinic nurse at each visit (regular pediatric visits and monthly clinic appointments until 12 months of age.)", 'armGroupLabels': ['High-iron']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santiago', 'country': 'Chile', 'facility': 'Instituto de Nutriticion y Tecnologia de los Alimentos', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Betsy Lozoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Betsy Lozoff, MD, Professor of Pediatrics and Communicable Diseases and Research Professor, Center for Human Growth and Development', 'oldOrganization': 'University of Michigan'}}}}