Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
Study NCT ID:
NCT02096250
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2014-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Iron Absorption in Haiti
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C019179', 'term': 'Fe(III)-EDTA'}, {'id': 'C031621', 'term': 'ferrous fumarate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2014-03-21', 'studyFirstSubmitQcDate': '2014-03-24', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Iron absorption', 'timeFrame': '14 days after test meal consumption'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Iron Deficiency']}, 'descriptionModule': {'briefSummary': 'The government of Haiti plans to introduce a flour fortification program. The aim of the project it to inform the authorities on the most suitable iron compound for this fortification program. For this purpose, iron absorption from wheat flour using different iron compounds will be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Mother-child pairs will be recruited!\n\nInclusion criteria for mothers :\n\n* Women of reproductive age (18 to 45 years)\n* Generally healthy\n* Consenting to study participation\n\nExclusion criteria for mothers :\n\n* Pregnancy or lactation\n* Weight \\>65 kg\n* Chronic illnesses which may influence iron absorption\n* Severe anemia (Hb\\<10 g/dl)\n\nInclusion criteria for children:\n\n* Age 4 years +/- 12 months\n* Generally healthy\n\nExclusion criteria for children :\n\n* Severe anemia (Hb\\<10 g/dl)\n* Weight for height \\< -2 Z scores (wasting)\n* Height of age \\< -2 Z score (stunting)\n\nFurthermore, the following exclusion criteria apply to both mothers and children :\n\n* Chronic illnesses or medication which may influence iron absorption (will be judged by investigator)\n* Consumption of vitamin or mineral supplement (unless they agree to discontinue using them two weeks before beginning of the study until the las visit)\n* Allergies or intolerances relevant to the test meal (gluten)\n* Blood donation or major blood losses during the 2 months prior to the study\n* Illness during the 4 weeks prior to the study (will be judged by investigator)'}, 'identificationModule': {'nctId': 'NCT02096250', 'briefTitle': 'Iron Absorption in Haiti', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'Iron Absorption From Wheat Flour in Haiti', 'orgStudyIdInfo': {'id': 'EK 2013-N43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NaFeEDTA', 'description': 'NaFeEDTA', 'interventionNames': ['Other: NaFeEDTA']}, {'type': 'EXPERIMENTAL', 'label': 'Ferrous fumarate', 'description': 'Ferrous fumarate', 'interventionNames': ['Other: Ferrous fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'NaFeEDTA + ferrous fumarate', 'description': 'NaFeEDTA + ferrous fumarate', 'interventionNames': ['Other: NaFeEDTA + ferrous fumarate']}], 'interventions': [{'name': 'NaFeEDTA', 'type': 'OTHER', 'armGroupLabels': ['NaFeEDTA']}, {'name': 'Ferrous fumarate', 'type': 'OTHER', 'armGroupLabels': ['Ferrous fumarate']}, {'name': 'NaFeEDTA + ferrous fumarate', 'type': 'OTHER', 'armGroupLabels': ['NaFeEDTA + ferrous fumarate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Port-au-Prince', 'country': 'Haiti', 'facility': 'Ministère de la Santé Publique et de la Population', 'geoPoint': {'lat': 18.54349, 'lon': -72.33881}}], 'overallOfficials': [{'name': 'Isabelle Aeberli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ETH Zurich (Switzerland)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Atomic Energy Agency', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Isabelle Aeberli', 'investigatorAffiliation': 'Swiss Federal Institute of Technology'}}}}