Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:12 AM
Study NCT ID:
NCT07315295
Status:
RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D015362', 'term': 'Child Nutrition Disorders'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D000067011', 'term': 'Severe Acute Malnutrition'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional Iron Absorption', 'timeFrame': 'Day 0'}, {'measure': 'Fractional Iron Absorption', 'timeFrame': 'Day 20'}, {'measure': 'Fractional Iron Absorption', 'timeFrame': 'Day 40'}, {'measure': 'Fractional Iron Absorption', 'timeFrame': 'Day 60'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin', 'timeFrame': 'Day 0', 'description': 'Iron status parameter'}, {'measure': 'Hemoglobin', 'timeFrame': 'Day 20', 'description': 'Iron status parameter'}, {'measure': 'Hemoglobin', 'timeFrame': 'Day 40', 'description': 'Iron status parameter'}, {'measure': 'Hemoglobin', 'timeFrame': 'Day 60', 'description': 'Iron status parameter'}, {'measure': 'Hemoglobin', 'timeFrame': 'Day 80', 'description': 'Iron status parameter'}, {'measure': 'Serum ferritin', 'timeFrame': 'Day 0', 'description': 'Iron status parameter'}, {'measure': 'Serum Ferritin', 'timeFrame': 'Day 20', 'description': 'Iron status parameter'}, {'measure': 'Serum Ferritin', 'timeFrame': 'Day 40', 'description': 'Iron status parameter'}, {'measure': 'Serum Ferritin', 'timeFrame': 'Day 60', 'description': 'Iron status parameter'}, {'measure': 'soluble transferrin receptor', 'timeFrame': 'Day 0', 'description': 'Iron status parameter'}, {'measure': 'soluble transferrin receptor', 'timeFrame': 'Day 20', 'description': 'Iron status parameter'}, {'measure': 'soluble transferrin receptor', 'timeFrame': 'Day 40', 'description': 'Iron status parameter'}, {'measure': 'soluble transferrin receptor', 'timeFrame': 'Day 60', 'description': 'Iron status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'Day 0', 'description': 'inflammation status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'Day 20', 'description': 'inflammation status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'Day 40', 'description': 'inflammation status parameter'}, {'measure': 'C-reactive protein', 'timeFrame': 'Day 60', 'description': 'inflammation status parameter'}, {'measure': 'α₁-acid glycoprotein', 'timeFrame': 'Day 0', 'description': 'inflammation status parameter'}, {'measure': 'α₁-acid glycoprotein', 'timeFrame': 'Day 20', 'description': 'inflammation status parameter'}, {'measure': 'α₁-acid glycoprotein', 'timeFrame': 'Day 40', 'description': 'inflammation status parameter'}, {'measure': 'α₁-acid glycoprotein', 'timeFrame': 'Day 60', 'description': 'inflammation status parameter'}, {'measure': 'body weight', 'timeFrame': 'Day 0'}, {'measure': 'body weight', 'timeFrame': 'Day 20'}, {'measure': 'body weight', 'timeFrame': 'Day 40'}, {'measure': 'body weight', 'timeFrame': 'Day 60'}, {'measure': 'body height', 'timeFrame': 'Day 0'}, {'measure': 'body height', 'timeFrame': 'Day 20'}, {'measure': 'body height', 'timeFrame': 'Day 40'}, {'measure': 'body height', 'timeFrame': 'Day 60'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ready to use therapeutic foods (RUFTs)', 'Severe acute malnutrition (SAM)', 'Stable isotopes', 'Iron bioavailability'], 'conditions': ['Iron Absorption', 'Iron Deficiencies', 'Severly Acutely Malnourished Children', 'Malnutrition in Children', 'Anemia']}, 'descriptionModule': {'briefSummary': 'Reports from the Kenya Red Cross Society (KRCS) in Kwale County, southern Kenya, indicate a limited impact of Ready-to-Use Therapeutic Foods (RUTFs) on malnutrition or anemia. The current RUTF formulation may have an excessively high iron content. In severely acutely malnourished (SAM) children, iron cannot be properly absorbed, leading to life-threatening diarrhea. The overall aim of this project is to develop an improved RUTF treatment that addresses acute malnutrition and anemia in children, ensuring both safety and efficacy. Specifically, to assess the impact of malnutrition on fractional iron absorption (FIA) from RUTFs in children, by comparing healthy children to those with acute malnutrition and by tracking changes in FIA in malnourished children over the course of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '54 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nmalnourished children:\n\n* severe acute malnutrition (SAM): WHZ \\< -3.0\n* moderate acute malnutrition (MAM): WHZ \\< -2.0 a\n* treated as outpatients (no acute medical conditions and a positive appetite test)\n\nhealthy children:\n\n\\- healthy: HAZ, WAZ and WHZ = 0\n\nExclusion Criteria (both groups):\n\n* Hemoglobin ≤7 g/dL\n* Presence of acute medical conditions requiring inpatient management'}, 'identificationModule': {'nctId': 'NCT07315295', 'acronym': 'SAMI', 'briefTitle': 'Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya', 'organization': {'class': 'OTHER', 'fullName': 'ETH Zurich'}, 'officialTitle': 'Maximizing the Benefits of Iron in Ready-to-use Therapeutic Foods for Malnourished Children in Kenya', 'orgStudyIdInfo': {'id': 'SAMI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy children', 'description': 'Healthy children', 'interventionNames': ['Other: Iron absorption from RUTF on Day 0']}, {'type': 'EXPERIMENTAL', 'label': 'Children with MAM/SAM', 'description': 'children with moderate or severe acute malnutrition', 'interventionNames': ['Other: Iron absorption from RUTF on Day 0', 'Dietary Supplement: Treatment with RUTF for 80 days', 'Other: Iron absorption from RUTF on Day 20', 'Other: Iron absorption from RUTF on Day 40', 'Other: Iron absorption from RUTF on Day 60']}], 'interventions': [{'name': 'Iron absorption from RUTF on Day 0', 'type': 'OTHER', 'description': 'RUFT with 57Fe', 'armGroupLabels': ['Children with MAM/SAM', 'Healthy children']}, {'name': 'Treatment with RUTF for 80 days', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily RUTF intake', 'armGroupLabels': ['Children with MAM/SAM']}, {'name': 'Iron absorption from RUTF on Day 20', 'type': 'OTHER', 'description': 'RUFT with 57Fe', 'armGroupLabels': ['Children with MAM/SAM']}, {'name': 'Iron absorption from RUTF on Day 40', 'type': 'OTHER', 'description': 'RUFT with 57Fe', 'armGroupLabels': ['Children with MAM/SAM']}, {'name': 'Iron absorption from RUTF on Day 60', 'type': 'OTHER', 'description': 'RUFT with 57Fe', 'armGroupLabels': ['Children with MAM/SAM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Msambweni', 'state': 'Kwale County', 'status': 'RECRUITING', 'country': 'Kenya', 'contacts': [{'name': 'Suzane Nyilima', 'role': 'CONTACT', 'email': 'suzane.nyilima@gmail.com', 'phone': '+254702836210'}], 'facility': 'ETH/Oxford/JKUAT research facility', 'geoPoint': {'lat': -4.4619, 'lon': 39.48265}}, {'zip': '8006', 'city': 'Zurich', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Prof. Dr. Stoffel', 'role': 'CONTACT', 'email': 'nicole.stoffel@pharma.ethz.ch', 'phone': '+41 44 632 83 93'}], 'facility': 'ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Suzane Nyilima, MSc', 'role': 'CONTACT', 'email': 'suzane.nyilima@gmail.com', 'phone': '+254702836210'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ETH Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistantprofessor', 'investigatorFullName': 'Nicole Stoffel', 'investigatorAffiliation': 'ETH Zurich'}}}}