Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-01-11 @ 9:03 PM
Study NCT ID:
NCT03305705
Status:
UNKNOWN
Last Update Posted:
2017-10-13
First Post:
2017-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patients will be blinded with respect to the treatment sequence. The outcome assessor (PET scan evaluator) will be blinded with respect to the participant identity and the date of the PET scan.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-10-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-12', 'studyFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2017-10-09', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dopamine (DA) receptor density', 'timeFrame': '6 weeks', 'description': 'Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer'}], 'secondaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': '6 weeks', 'description': 'Reduction of fatigue after iron supplementation determined by Fatigue Assessment Scale (FAS)'}, {'measure': 'Fatigue', 'timeFrame': '6 weeks', 'description': 'Reduction of fatigue after iron supplementation determined by "Würzburger Erschöpfungs-Inventar bei Multipler Sklerose" (WEIMuS, in German) questionaire'}, {'measure': 'Neuropsychological symptoms', 'timeFrame': '6 weeks', 'description': 'Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fatigue', 'Iron-deficiency']}, 'descriptionModule': {'briefSummary': 'This study investigates the effect of intravenous iron substitution in non-anaemic premenopausal women with iron deficiency on:\n\n* Changes in the cerebral Dopamine (DA) receptor density after iron substitution, shown by brain PET\n* Reduction of fatigue and other neuropsychological symptoms after iron supplementation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female subjects, Age \\> 18 years, premenopausal, regularly menstruating\n* BMI 18-25 kg/m2\n* Serum ferritin level \\< 15 μg/ml, Hb \\> 120 g/L\n* Adequate contraception during the study period\n* Fatigue determined as 2 or more points in the basic questionnaire for fatigue\n* Informed consent\n\nExclusion Criteria:\n\n* Day-night shift work\n* 11 or more points in the BDI\n* No psychiatric disease (as assessed by neuropsychiatric assessment)\n* 15 or more points in the ISI\n* Known hypersensitivity to iron carboxymaltose, iron sucrose or iron sulfate\n* Intake of iron preparations during the last 8 weeks before the start of the trial protocol\n* Pregnancy or lactation\n* Any cardiovascular or pulmonary disease\n* Acute or chronic infection/inflammation or malignancy\n* Other obvious physical or psychiatric causes for fatigue (known mental disorders, e.g. depression)\n* Chronic intake of concurrent medication (especially antipsychotic drugs), except oral contraceptives. Sporadic intake of NSAID or paracetamol, e.g. in the case of a common cold or sporadic headaches is allowed.\n* CRP \\> 10 mg/L\n* TSH out of normal range\n* Any concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.\n* Participation in any other therapeutic trial within the previous month\n* Known History of HIV/HBV/HCV'}, 'identificationModule': {'nctId': 'NCT03305705', 'briefTitle': 'Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Double-Blind, Single-Center Interventional Trial To Evaluate The Effect Of Intravenous Iron Versus Placebo On Cerebral Dopamine Receptor Density In Non Anaemic Premenopausal Women With Low Ferritin Levels And Fatigue', 'orgStudyIdInfo': {'id': 'BASEC-Nr. PB_2017-00429'}, 'secondaryIdInfos': [{'id': 'KEK-ZH-Nr. 2014-0217', 'type': 'OTHER', 'domain': 'KEK Zurich'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 1', 'description': 'Patients will be treated with 0.9% sodium chloride (placebo) at Visit 1 and with iron carboxymaltose in 6 weeks at Visit 2. The patients will be blinded with respect to the treatment sequence.', 'interventionNames': ['Drug: Iron Carboxymaltose', 'Drug: Sodium chloride 0.9%']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 2', 'description': 'Patients will be treated with 0.9% sodium chloride (placebo) at Visit 1 and with iron carboxymaltose in 6 weeks at Visit 2. The patients will be blinded with respect to the treatment sequence.', 'interventionNames': ['Drug: Iron Carboxymaltose', 'Drug: Sodium chloride 0.9%']}], 'interventions': [{'name': 'Iron Carboxymaltose', 'type': 'DRUG', 'otherNames': ['Ferinject®'], 'description': 'Single intravenous infusion within 20 min', 'armGroupLabels': ['Treatment Arm 1', 'Treatment Arm 2']}, {'name': 'Sodium chloride 0.9%', 'type': 'DRUG', 'otherNames': ['NaCl 0.9 % (serves as Placebo)'], 'description': 'Single intravenous infusion of 250 ml within 20 min', 'armGroupLabels': ['Treatment Arm 1', 'Treatment Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'contacts': [{'name': 'Yulia Butscheid, PhD', 'role': 'CONTACT', 'email': 'iron-dopamine@usz.ch'}, {'name': 'Yulia Butscheid, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Albina Nowak, MD', 'role': 'CONTACT', 'email': 'albina.nowak@usz.ch', 'phone': '+41 (0)44 255 10 54'}], 'overallOfficials': [{'name': 'Albina Nowak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albina Nowak, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'senior physician', 'investigatorFullName': 'Albina Nowak, MD', 'investigatorAffiliation': 'University of Zurich'}}}}