Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT02977806
Status:
UNKNOWN
Last Update Posted:
2019-04-02
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Long-Term Labelling Study Malawi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2016-11-28', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'iron isotope composition in blood', 'timeFrame': '2 years', 'description': 'the iron isotope ratio (tracer/tracee ratio) in blood should be analyzed with ICPMS every 120 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Iron Absorption']}, 'descriptionModule': {'briefSummary': 'Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections in sub-Saharan Africa, a region with a high prevalence of iron deficiency, making the assessment of iron balance and efficiency of iron intervention difficult. A new method allowing accurate measurement of long-term oral iron absorption and allowing the estimation of iron requirements is highly needed. Such a novel method to quantify iron absorption and requirements using isotope dilution measurements in children should be validated in the present prospective observational study by following-up a group of 49 children given a stable iron isotope in an earlier trial. We will request seven blood samples within 2 years (sampling every four months) from the participants which will allow us to measure isotopic dilution for estimating total oral iron absorption over these 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Malawian children who ingested stable iron isotopes in the frame of a former iron absorption study.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have participated in the original absorption study and the two follow-up samplings\n* Signed written informed consent from the guardian to participate in the study\n\nExclusion Criteria:\n\n* Long-term medication\n* Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the guardian's statement or med-ical examination (health booklet))\n* Blood losses (surgery, accident) or blood transfusion during the past 4 months before study start.\n* Residence too far away (\\> 2 hours by motorbike) from study location (Zomba)"}, 'identificationModule': {'nctId': 'NCT02977806', 'briefTitle': 'Iron Long-Term Labelling Study Malawi', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'The Evaluation of Iron Metabolism Using a Novel Isotope Dilution Method in Malawian Children, Who Have Previously Participated in a Stable Isotope Study', 'orgStudyIdInfo': {'id': 'Fe_LTL_Ma'}}, 'contactsLocationsModule': {'locations': [{'zip': '03', 'city': 'Blantyre', 'country': 'Malawi', 'facility': 'College of Medicine', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}], 'overallOfficials': [{'name': 'Michael Zimmermann, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Human Nutrition Laboratory, ETH Zürich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Michael B. Zimmermann', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Prof. Michael B. Zimmermann', 'investigatorAffiliation': 'Swiss Federal Institute of Technology'}}}}