Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-29 @ 2:49 PM
Study NCT ID:
NCT04855266
Status:
WITHDRAWN
Last Update Posted:
2023-06-13
First Post:
2021-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iron Sucrose in Patients With Iron Deficiency and POTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D054972', 'term': 'Postural Orthostatic Tachycardia Syndrome'}], 'ancestors': [{'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'}, {'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013395', 'term': 'Sucrose'}, {'id': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}, {'id': 'D018667', 'term': 'Tilt-Table Test'}], 'ancestors': [{'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to recruit participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-04-19', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in autonomic dysfunction symptoms', 'timeFrame': 'Baseline, 7 days, 6 months', 'description': 'Measured using the self-reported Composite Autonomic Symptom Score (COMPASS) questionnaire that asks 31 questions regarding symptoms of autonomic dysfunction'}, {'measure': 'Change in postural heart rate increase', 'timeFrame': 'Baseline, 7 days', 'description': 'Heart rate change during tilt table test measured in beats per minute'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron-deficiency', 'Postural Orthostatic Tachycardia Syndrome']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with Postural Orthostatic Tachycardia syndrome (POTS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (age 12 to years and older) with chronic (\\>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations.\n* Symptomatic orthostatic heart rate increment ≥30 bpm if \\>19 years old or ≥40 bpm if \\<19 years old during a 10 minute 70 degree head up tilt study\n* Presence of non-anemic iron deficiency, defined as serum ferritin levels \\<20 ug/L with hemoglobin no less than 1 gm/dL below the normal reference range as defined for age and gender\n* Consent obtained from responsible guardian AND from subjects, 12-17 years of age\n* Consent obtained for subjects 18 years of age and older\n\nExclusion Criteria:\n\n* Orthostatic hypotension (decrease of systolic BP\\>30 mmHg and/or diastolic BP\\>15mmHg within 3 minutes of 70 degree head up tilt study)\n* Pregnant or lactating females\n* The presence of failure of other organ systems or systemic illness that can affect autonomic function\n* Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study\n* Laboratory evidence of anemia or iron overload\n* Personal history of hematochromatosis or first degree relative with hematochromatosis\n* Known sensitivity to Venofer® (iron sucrose injection, USP) or other intravenous iron preparation'}, 'identificationModule': {'nctId': 'NCT04855266', 'briefTitle': 'Iron Sucrose in Patients With Iron Deficiency and POTS', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Randomized, Controlled, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Intravenous Iron Sucrose in Patients With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)', 'orgStudyIdInfo': {'id': '21-000488'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iron Sucrose Group', 'description': 'Subjects will receive intravenous iron sucrose during a tilt table test', 'interventionNames': ['Drug: Sucrose', 'Diagnostic Test: Tilt Table Test']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects will receive intravenous placebo during a tilt table test', 'interventionNames': ['Drug: Placebo', 'Diagnostic Test: Tilt Table Test']}], 'interventions': [{'name': 'Sucrose', 'type': 'DRUG', 'otherNames': ['Venofer'], 'description': '5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted', 'armGroupLabels': ['Iron Sucrose Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Normal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL)', 'armGroupLabels': ['Placebo Group']}, {'name': 'Tilt Table Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'A table that adjusts the body position from horizontal to vertical to simulate standing up. Heart rate and blood pressure are monitored throughout the test.', 'armGroupLabels': ['Iron Sucrose Group', 'Placebo Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kamal Shouman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kamal Shouman', 'investigatorAffiliation': 'Mayo Clinic'}}}}