Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-04-03 @ 11:24 PM
Study NCT ID:
NCT03777904
Status:
TERMINATED
Last Update Posted:
2022-04-05
First Post:
2018-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019190', 'term': 'Iron Overload'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Analysis of first 11 subjects resulted in values that were too varied to make the study feasible.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2018-12-14', 'studyFirstSubmitQcDate': '2018-12-14', 'lastUpdatePostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of serum and urine ferritin levels', 'timeFrame': '1 year', 'description': 'Serum levels of ferritin will be compared to urine ferritin levels to evaluate whether urine can be used to calculate ferritin levels in the body non-invasively'}, {'measure': 'Correlation of iron content within serum and urine ferritin levels', 'timeFrame': '1 year', 'description': 'Serum iron content of ferritin will be compared to urine iron content of ferritin levels to evaluate whether urine can be used to calculate total body iron content non-invasively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Overload']}, 'descriptionModule': {'briefSummary': 'A serum ferritin level can reflect the total body iron content, thus a very low serum ferritin is commonly used as an indicator of iron deficiency and a very high serum ferritin is commonly used as a marker of iron overload. Ferritin is a shell of protein in which iron is stored. Ferritin is an acute phase reactant, and serum ferritin levels can increase during inflammatory conditions. Consequently, an elevated ferritin level might mean there is an excess of storage iron, or might simply mean that inflammation has resulted in high levels of the ferritin shell, containing little iron.\n\nThe research team is able to quantify the amount of iron in ferritin using inductively conducted plasma mass spectrometry, in the Heme and Iron Core Laboratory at the University of Utah. Thus, it can be determined whether in a child with a very high serum ferritin level, that ferritin is loaded with iron or is actually very low in iron. Neonates and young children with certain liver disorders characteristically have a very high serum ferritin level. These conditions are gestational alloimmune liver disease (GALD) and hemophagocytic lymphohistiocytosis (HLH). It is not clear what the iron content of the ferritin is in these neonates. Knowing this will be a step toward understanding whether the pathogenesis of these conditions involves iron overload. Additionally, if urine ferritin and iron levels correlate with serum ferritin and iron levels, urine may be used as a non-invasive way to monitor iron status.\n\nIn this study, serum and urine samples will be collected from children with high serum ferritin levels and confirmed iron toxicity. Both ferritin and iron content within ferritin will be measured in the serum and urine samples and compared for correlation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with high ferritin levels and confirmed iron toxicity.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with ferritin levels \\> 1000 ng/mL\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03777904', 'briefTitle': 'The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'The Iron Content of Ferritin in Serum and Urine of Children With High Serum Ferritin Levels', 'orgStudyIdInfo': {'id': '00117617'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with high serum ferritin', 'description': 'Children with very high serum ferritin levels and confirmed iron toxicity will have a urine sample and blood sample drawn at the same time. Both samples will have ferritin levels and iron content measured and compared for correlation.', 'interventionNames': ['Diagnostic Test: Serum Ferritin level', 'Diagnostic Test: Serum Ferritin iron content', 'Diagnostic Test: Urine Ferritin level', 'Diagnostic Test: Urine ferritin iron content']}], 'interventions': [{'name': 'Serum Ferritin level', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum ferritin level will be collected with other clinical labs and measured in the research lab', 'armGroupLabels': ['Children with high serum ferritin']}, {'name': 'Serum Ferritin iron content', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood will be collected with other clinical labs and the iron content in the ferritin will be measured in the research lab', 'armGroupLabels': ['Children with high serum ferritin']}, {'name': 'Urine Ferritin level', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urine will be collected non-invasively and analyzed for ferritin level', 'armGroupLabels': ['Children with high serum ferritin']}, {'name': 'Urine ferritin iron content', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urine will be collected non-invasively and analyzed for iron content within the ferritin', 'armGroupLabels': ['Children with high serum ferritin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Robert Christensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}