Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT06238895
Status:
RECRUITING
Last Update Posted:
2024-10-26
First Post:
2024-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Dosing Strategies in Oral Iron Supplementation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009380', 'term': 'ferrous sulfate, mucin drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Hemoglobin after 12 weeks', 'timeFrame': '12 weeks', 'description': 'Change (from baseline before treatment) of hemoglobin after 12 weeks of oral iron supplementation'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants achieving treatment goal', 'timeFrame': '12 weeks', 'description': 'Proportion of participants achieving either increase of hemoglobin (\\>20 g/l), normalization of hemoglobin (women \\>120 g/l, pregnant women \\>110 g/l and men \\>130 g/l) after 12 weeks of oral iron supplementation'}, {'measure': 'Change of iron parameters from baseline', 'timeFrame': '12 weeks', 'description': 'Change of iron parameters from baseline compared to after treatment of 12 weeks'}, {'measure': 'Side effects', 'timeFrame': '12 weeks', 'description': 'Side effects during treatment with oral iron supplementation in both groups (intervention and active control)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iron deficiency anemia', 'oral iron supplementation', 'iron supplementation', 'gender differences'], 'conditions': ['Iron Deficiencies', 'Iron Deficiency Anemia', 'Iron Deficiency Anemia Treatment']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate, if a change in dosing strategy in oral iron supplementation from leads to an improvement of iron absorption and consequently a faster therapy in patients with iron deficiency.\n\nThe main question the study aims to answer is: Does a treatment effect (measured by change in hemoglobin after 12 weeks of treatment) exist between daily oral iron supplementation and interval administration (every second day)? Participants will receive oral iron supplementation every second day with double the standard dose (intervention group). Researchers will compare this group with the active control group, that receives oral iron supplementation every day with the standard dose.\n\nParticipants will present for three patient visits (at baseline, after 6 and after 12 weeks of treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent signed by the subject\n* ≥18 years of age\n* Iron deficiency: Ferritin \\<30 µg/l\n* hemoglobin ≥ 80 g/l\n* CRP \\< 5 mg/l\n\nExclusion Criteria:\n\n* Refusal of study participation,\n* Regular administration of Erythropoietin\n* Oral or intravenous iron supplementation \\<12 weeks prior to investigation\n* Contraindications to intervention medication (Tardyferon), e.g. known hypersensitivity or allergy to iron sulfate / ferrous sulfate\n* Blood transfusion or donation \\<12 weeks prior to investigation\n* Active chemotherapy\n* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject.\n\nNote\n\nDue to slow recruitment, the following inclusion criterion was removed on 09/25/2024 (MM/DD/YYYY):\n\nAnemia (as defined by the WHO): Hemoglobin \\<130 g/L for men, Hemoglobin \\<120 g/l for women, Hemoglobin \\<110 g/l for pregnant women'}, 'identificationModule': {'nctId': 'NCT06238895', 'acronym': 'OPTIDOSE', 'briefTitle': 'Optimizing Dosing Strategies in Oral Iron Supplementation', 'organization': {'class': 'OTHER', 'fullName': 'Luzerner Kantonsspital'}, 'officialTitle': 'Optimizing Dosing Strategies in Oral Iron Supplementation', 'orgStudyIdInfo': {'id': '2023-02317'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every second day 2 x 80 mg Tardyferon® for a duration of 12 weeks.', 'interventionNames': ['Drug: Tardyferon']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Control', 'description': 'Oral iron supplementation with Eisen-II-Sulfat (Tardyferon ®) Every day 1x 80 mg Tardyferon® for a duration of 12 weeks', 'interventionNames': ['Drug: Tardyferon']}], 'interventions': [{'name': 'Tardyferon', 'type': 'DRUG', 'description': 'Interval Dosing Strategy (Administration of oral iron every second day with double the standard dose instead of every day standard dose)', 'armGroupLabels': ['Active Control', 'Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lucerne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Meyer', 'role': 'CONTACT', 'phone': '+41 41 205 11 11'}], 'facility': 'Luzerner Kantonsspital', 'geoPoint': {'lat': 47.05048, 'lon': 8.30635}}], 'centralContacts': [{'name': 'Meyer', 'role': 'CONTACT', 'email': 'eisenstudie@luks.ch', 'phone': '+41 41 205 11 11'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luzerner Kantonsspital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Helene Meyer', 'investigatorAffiliation': 'Luzerner Kantonsspital'}}}}