Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 9:01 AM
Study NCT ID:
NCT04636060
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2020-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient 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': 'D019266', 'term': 'Iron, Dietary'}], 'ancestors': [{'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-16', 'studyFirstSubmitDate': '2020-11-09', 'studyFirstSubmitQcDate': '2020-11-14', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase of serum ferritin concentration under iron supplementation', 'timeFrame': '8 weeks', 'description': 'significant increase of serum-ferritin concentration after 8 weeks of low-dose iron-supplementation'}], 'secondaryOutcomes': [{'measure': 'Side-effects of treatment', 'timeFrame': '8 weeks', 'description': 'Adverse events will be assessed on a report form after 8 weeks'}, {'measure': 'Serum hepcidin concentration', 'timeFrame': '8 weeks', 'description': 'no increase in hepcidin-production during low-dose iron supplementation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Deficiency (Without Anemia)']}, 'referencesModule': {'references': [{'pmid': '37229775', 'type': 'DERIVED', 'citation': 'Simic S, Karczewski M, Klapdor S, Nowak A, Schubert M, Moretti D, Swinkels DW, Beuschlein F, Saleh L, Suter P, Krayenbuehl PA. Effectiveness of low-dose iron treatment in non-anaemic iron-deficient women: a prospective open-label single-arm trial. Swiss Med Wkly. 2023 May 25;153:40079. doi: 10.57187/smw.2023.40079.'}]}, 'descriptionModule': {'briefSummary': 'Iron deficiency is common in Switzerland and the main reason for anaemia. Nearly one in five premenopausal women suffers from iron deficiency. Low iron intake, reduced iron resorption or loss of blood are the main cause for iron deficiency. Symptoms of iron deficiency, for example fatigue, weakness, headache or exercise intolerance are primarily due to anaemia, but the same symptoms may also be present in non-anaemic patients with low serum ferritin. Consequently it is important to detect and treat non-anaemic iron deficiency. Common side effects of oral iron supplementation are primarily gastrointestinal symptoms like nausea, vomiting, diarrhea or abdominal pain. There is a positive correlation between appearance of gastrointestinal symptoms and administered iron dose. To date, only few studies have investigated effectiveness of low-dose iron supplementation in different target groups. The aim of this study is to investigate if low dose iron supplementation with 12mg iron per day for 8 weeks is sufficient to increase serum ferritin levels into a normal range in healthy premenopausal women suffering from non-anaemic iron deficiency'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Female gender\n* Premenopausal\n* Age \\> 18 years\n* Regular menstrual cycle\n* BMI in normal range (18-25 kg/m²)\n* Serum-ferritin \\<30ng/ml\n* No anaemia\n* symptomatic iron deficiency in the past\n* No intake of dietary supplements\n\nExclusion Criteria\n\n* Intake of dietary supplements\n* Pregnancy\n* Hypermenorrhea\n* Anaemia\n* Serum-ferritin \\>30ng/ml\n* BMI \\<18 kg/m² or \\>25 kg/m²\n* chronic inflammatory diseases (e.g. colitis)\n* Hypersensitivity to iron-supplements\n* psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT04636060', 'briefTitle': 'Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Single Center Clinical Trial to Evaluate the Effectiveness of Low-dose Iron Treatment in Non-anaemic Iron-deficient Women', 'orgStudyIdInfo': {'id': 'LowdoseIron'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron-treatment group', 'interventionNames': ['Dietary Supplement: Eisen']}], 'interventions': [{'name': 'Eisen', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Treatment with low-dose iron in the form of tablets containing 6mg of iron. Treatment consists of twice-daily oral administration of iron-tablets for 8 weeks in total.', 'armGroupLabels': ['Iron-treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsspital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Pierre-Alexandre Krayenbühl', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Pierre-Alexandre Krayenbuehl', 'investigatorAffiliation': 'University of Zurich'}}}}