Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-01-11 @ 9:06 PM
Study NCT ID:
NCT02671695
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2016-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017086', 'term': 'beta-Thalassemia'}], 'ancestors': [{'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2016-01-30', 'studyFirstSubmitQcDate': '2016-01-30', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac iron concentration by magnetic resonance imaging', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'cardiac troponin 1', 'timeFrame': '3 months'}, {'measure': 'N-terminal pro-brain natriuretic peptide', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Beta Thalassemia Major']}, 'referencesModule': {'references': [{'pmid': '37975597', 'type': 'DERIVED', 'citation': 'Padhani ZA, Gangwani MK, Sadaf A, Hasan B, Colan S, Alvi N, Das JK. Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia. Cochrane Database Syst Rev. 2023 Nov 17;11(11):CD011626. doi: 10.1002/14651858.CD011626.pub3.'}]}, 'descriptionModule': {'briefSummary': 'the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload and cardiac functions in multi-transfused children with beta thalassemia major', 'detailedDescription': 'the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload using magnetic resonance imaging and cardiac functions in multi-transfused children with beta thalassemia major'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients on regular blood transfusions.\n* iron overload with no perspective of changing the chelation therapy in the following three months\n\nExclusion Criteria:\n\n* formal contraindication to magnetic resonance examinations\n* implantable cardiac device\n* advanced cardiomyopathy or conduction block\n* other types of hemolytic anemias'}, 'identificationModule': {'nctId': 'NCT02671695', 'briefTitle': 'Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia', 'orgStudyIdInfo': {'id': '22/03/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months', 'interventionNames': ['Drug: Spirulina']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months', 'interventionNames': ['Drug: Amlodipine']}], 'interventions': [{'name': 'Spirulina', 'type': 'DRUG', 'description': 'Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months', 'armGroupLabels': ['Group 1']}, {'name': 'Amlodipine', 'type': 'DRUG', 'description': 'Amlodipine in a dose of 5 mg/day orally for 3 months', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Medicine- Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Sahar M El-Haggar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'assisstant professor of clinical pharmacy- Faculty of Pharmacy- Tanta University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of pediatric hematology and oncology unit', 'investigatorFullName': 'Professor Mohamed Elshanshory', 'investigatorAffiliation': 'Tanta University'}}}}