Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-03-02 @ 10:05 PM
Study NCT ID:
NCT01404533
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2011-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women
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': 'C020748', 'term': 'ferrous sulfate'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-05', 'studyFirstSubmitDate': '2011-07-27', 'studyFirstSubmitQcDate': '2011-07-27', 'lastUpdatePostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Formation of NTBI following oral iron administration', 'timeFrame': '6 time points within 8 hours'}], 'secondaryOutcomes': [{'measure': 'Serum iron isotope appearance curves', 'timeFrame': '6 time points within 8 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NTBI', 'Iron', 'Absorption'], 'conditions': ['Iron Deficiency']}, 'referencesModule': {'references': [{'pmid': '25057155', 'type': 'DERIVED', 'citation': 'Brittenham GM, Andersson M, Egli I, Foman JT, Zeder C, Westerman ME, Hurrell RF. Circulating non-transferrin-bound iron after oral administration of supplemental and fortification doses of iron to healthy women: a randomized study. Am J Clin Nutr. 2014 Sep;100(3):813-20. doi: 10.3945/ajcn.113.081505. Epub 2014 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this research is to develop safe and effective iron interventions that can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in the systemic circulation not bound to the iron-transport protein transferrin). The appearance of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after oral administration of iron supplements in doses similar to those used in the Pemba trial. This research project will (i) confirm the appearance of plasma non-transferrin-bound iron after administration of an iron supplement like that in the Pemba trial (\\~1 mg Fe/kg body weight, without food), and then determine the effects on production of plasma non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of giving the supplemental iron (\\~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a lower dose of iron (\\~0.1 mg Fe/kg) - like that used in home fortification - with the standard rice meal.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non pregnant\n* non lactating\n* apparently healthy women\n\nExclusion Criteria:\n\n* chronic disease\n* pregnancy\n* lactation'}, 'identificationModule': {'nctId': 'NCT01404533', 'acronym': 'NTBIwomen', 'briefTitle': 'Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Federal Institute of Technology'}, 'officialTitle': 'The Influence of Iron Interventions on Formation of Non-transferrin-bound Iron (NTBI) in Women', 'orgStudyIdInfo': {'id': 'NTBI women'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron supplement without food', 'interventionNames': ['Dietary Supplement: Ferrous sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Iron supplement with food', 'interventionNames': ['Dietary Supplement: Ferrous sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Iron fortificant with food', 'interventionNames': ['Dietary Supplement: Ferrous sulfate']}], 'interventions': [{'name': 'Ferrous sulfate', 'type': 'DIETARY_SUPPLEMENT', 'description': '60 mg Ferrous sulfate', 'armGroupLabels': ['Iron supplement without food']}, {'name': 'Ferrous sulfate', 'type': 'DIETARY_SUPPLEMENT', 'description': '60 mg ferrous sulfate', 'armGroupLabels': ['Iron supplement with food']}, {'name': 'Ferrous sulfate', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 mg ferrous sulfate', 'armGroupLabels': ['Iron fortificant with food']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8092', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'ETH Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Richard Hurrell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ETH Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Federal Institute of Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Columbia University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}