Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-29 @ 4:43 AM
Study NCT ID:
NCT04517734
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2020-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000751', 'term': 'Anemia, Neonatal'}], 'ancestors': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'During pregnancy 15 mL maternal blood sample collected. At delivery 15 mL maternal blood sample, 20 mL umbilical cord blood sample and the placenta are collected.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 338}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-08', 'studyFirstSubmitDate': '2020-08-11', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal Erythroferrone During Pregnancy', 'timeFrame': 'Measures will be obtained from maternal blood collected throughout the 40 weeks of pregnancy'}, {'measure': 'Maternal Erythroferrone at Delivery', 'timeFrame': 'Measures will be obtained from maternal blood collected at delivery'}, {'measure': 'Neonatal Erythroferrone at Birth', 'timeFrame': 'Measures will be obtained from umbilical cord blood collected at delivery'}, {'measure': 'Placental Erythroferrone mRNA and Ferroportin protein Expression', 'timeFrame': 'Measures will be obtained from placental samples collected at delivery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Anemia', 'Newborn; Anemia']}, 'referencesModule': {'references': [{'pmid': '33982118', 'type': 'DERIVED', 'citation': "Delaney KM, Guillet R, Pressman EK, Ganz T, Nemeth E, O'Brien KO. Serum Erythroferrone During Pregnancy Is Related to Erythropoietin but Does Not Predict the Risk of Anemia. J Nutr. 2021 Jul 1;151(7):1824-1833. doi: 10.1093/jn/nxab093."}]}, 'descriptionModule': {'briefSummary': 'Erythroferrone (ERFE) is a recently identified iron-regulatory hormone that couples iron homeostasis to erythropoiesis but at this time there are no human data on this hormone in pregnant women and their neonates. The investigators hypothesize that ERFE is a sensitive biomarker of iron deficiency and anemia in pregnancy and neonates, and that it mediates the feedback mechanism to correct iron deficiency and anemia. To address this research gap, the investigators will measure ERFE in maternal serum, umbilical cord serum and placental tissue using an existing biospecimen archive.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women carrying multiple fetuses (twins, triplets and quadruplets) or pregnant adolescents carrying a single fetus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy pregnant volunteers\n\nExclusion Criteria:\n\n* Hemoglobinopathies\n* Pre-existing diabetes\n* Malabsorption diseases\n* Pregnancy induced hypertension\n* Elevated diastolic blood pressure (\\>110)\n* Previous treatment for lead exposure or elevated childhood lead concentrations.\n* Preexisting medical conditions known to impact iron homeostasis'}, 'identificationModule': {'nctId': 'NCT04517734', 'briefTitle': 'Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis', 'organization': {'class': 'OTHER', 'fullName': 'Cornell University'}, 'officialTitle': 'Erythroferrone and Its Impact on Maternal and Neonatal Iron Homeostasis', 'orgStudyIdInfo': {'id': '0911001050'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant Adolescents'}, {'label': 'Pregnant Women Carrying Multiple Fetuses'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Adolescent Maternity Program', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Strong Memorial Hospital', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': "Kimberly O'Brien, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cornell University'}, {'name': 'Elizabeta Nemeth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}