Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT05266703
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2022-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional iron absorption', 'timeFrame': 'Day 14', 'description': 'shift in iron isotopic ratios measured in red blood cells'}], 'secondaryOutcomes': [{'measure': 'Plasma Ferritin', 'timeFrame': 'Day 0'}, {'measure': 'Plasma Ferritin', 'timeFrame': '4 months after isotope administration'}, {'measure': 'Plasma Ferritin', 'timeFrame': '8 months after isotope administration'}, {'measure': 'Plasma Ferritin', 'timeFrame': '12 months after isotope administration'}, {'measure': 'soluble transferrin receptor', 'timeFrame': 'Day 0'}, {'measure': 'soluble transferrin receptor', 'timeFrame': '4 months after isotope administration'}, {'measure': 'soluble transferrin receptor', 'timeFrame': '8 months after isotope administration'}, {'measure': 'soluble transferrin receptor', 'timeFrame': '12 months after isotope administration'}, {'measure': 'C-reactive protein', 'timeFrame': 'Day 0'}, {'measure': 'C-reactive protein', 'timeFrame': '4 months after isotope administration'}, {'measure': 'C-reactive protein', 'timeFrame': '8 months after isotope administration'}, {'measure': 'C-reactive protein', 'timeFrame': '12 months after isotope administration'}, {'measure': 'alpha-1-glycoprotein', 'timeFrame': 'Day 0'}, {'measure': 'alpha-1-glycoprotein', 'timeFrame': '4 months after isotope administration'}, {'measure': 'alpha-1-glycoprotein', 'timeFrame': '8 months after isotope administration'}, {'measure': 'alpha-1-glycoprotein', 'timeFrame': '12 months after isotope administration'}, {'measure': 'Hemoglobin', 'timeFrame': 'Day 0'}, {'measure': 'Hemoglobin', 'timeFrame': '4 months after isotope administration'}, {'measure': 'Hemoglobin', 'timeFrame': '8 months after isotope administration'}, {'measure': 'Hemoglobin', 'timeFrame': '12 months after isotope administration'}, {'measure': 'Plasma Hepcidin', 'timeFrame': 'Day 0'}, {'measure': 'Isotopic composition of red blood cells', 'timeFrame': '4 months after isotope administration', 'description': 'shift in iron isotopic ratios measured in red blood cells'}, {'measure': 'Isotopic composition of red blood cells', 'timeFrame': '8 months after isotope administration', 'description': 'shift in iron isotopic ratios measured in red blood cells'}, {'measure': 'Isotopic composition of red blood cells', 'timeFrame': '12 months after isotope administration', 'description': 'shift in iron isotopic ratios measured in red blood cells'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron-deficiency', 'Ferritin Threshold', 'Iron Absorption', 'Stable Iron Isotopes']}, 'descriptionModule': {'briefSummary': 'The serum or plasma ferritin concentration (referred to hereafter as ferritin) is the most widely used indicator to detect iron deficiency and a low ferritin indicates depleted iron stores. However, the threshold ferritin that defines iron deficiency remains unclear and diagnostic ferritin cutoffs from expert groups vary widely.\n\nOur study aim is to define the ferritin in Kenyan young women at which the body senses iron depletion and begins to upregulate iron absorption from the diet; this approach could provide a functionally defined threshold of iron deficiency in Sub-Saharan African women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-28 y, not pregnant or lactating\n* Body weight \\<75 kg\n* body mass index (BMI) between 17 and 25 kg/m2\n* No acute illness/infection (self-reported)\n* No metabolic or gastrointestinal disorders (self-reported)\n* No use of medications affecting iron absorption or metabolism during the study\n* No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during the study'}, 'identificationModule': {'nctId': 'NCT05266703', 'briefTitle': 'Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption', 'orgStudyIdInfo': {'id': 'PILLAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Isotopically labelled iron sulfate 15mg', 'interventionNames': ['Other: Isotopically labelled iron sulfate 15mg']}], 'interventions': [{'name': 'Isotopically labelled iron sulfate 15mg', 'type': 'OTHER', 'description': 'test drink: water containing isotopic iron solution with vitamin C', 'armGroupLabels': ['Isotopically labelled iron sulfate 15mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Msambweni', 'country': 'Kenya', 'facility': 'Msambweni County Referral Hospital', 'geoPoint': {'lat': -4.4619, 'lon': 39.48265}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jomo Kenyatta University of Agriculture and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}