Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2026-01-03 @ 9:38 PM
Study NCT ID:
NCT02597595
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2015-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2015-09-05', 'studyFirstSubmitQcDate': '2015-11-03', 'lastUpdatePostDateStruct': {'date': '2018-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac functions measured by echocardiography', 'timeFrame': 'after 3 months of regular oral spirulina supplementation', 'description': 'Fractional shortening \\[FS\\]. Mitral flow early phase filling velocity \\[E\\], peak atrial phase filling velocity\\[A\\] and E/A ratio, and left ventricular (LV) diastolic function'}], 'secondaryOutcomes': [{'measure': 'cardiac functions measured by troponin-1 plasma level.', 'timeFrame': 'after 3 months of regular oral spirulina supplementation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Beta Thalassemia']}, 'referencesModule': {'references': [{'pmid': '16372368', 'type': 'BACKGROUND', 'citation': 'Khan M, Shobha JC, Mohan IK, Naidu MU, Sundaram C, Singh S, Kuppusamy P, Kutala VK. Protective effect of Spirulina against doxorubicin-induced cardiotoxicity. Phytother Res. 2005 Dec;19(12):1030-7. doi: 10.1002/ptr.1783.'}, {'pmid': '18404006', 'type': 'BACKGROUND', 'citation': 'Cogliandro T, Derchi G, Mancuso L, Mayer MC, Pannone B, Pepe A, Pili M, Bina P, Cianciulli P, De Sanctis V, Maggio A; Society for the Study of Thalassemia and Hemoglobinopathies (SoSTE). Guideline recommendations for heart complications in thalassemia major. J Cardiovasc Med (Hagerstown). 2008 May;9(5):515-25. doi: 10.2459/JCM.0b013e3282f20847.'}, {'pmid': '23775258', 'type': 'BACKGROUND', 'citation': 'Pennell DJ, Udelson JE, Arai AE, Bozkurt B, Cohen AR, Galanello R, Hoffman TM, Kiernan MS, Lerakis S, Piga A, Porter JB, Walker JM, Wood J; American Heart Association Committee on Heart Failure and Transplantation of the Council on Clinical Cardiology and Council on Cardiovascular Radiology and Imaging. Cardiovascular function and treatment in beta-thalassemia major: a consensus statement from the American Heart Association. Circulation. 2013 Jul 16;128(3):281-308. doi: 10.1161/CIR.0b013e31829b2be6. Epub 2013 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.', 'detailedDescription': 'The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.\n\nthis study will be carried on thirty children with beta thalassemia major from those attending the Hematology Unit of Pediatric department at Tanta University Hospital, and another thirty healthy children of matched age and sex will be enrolled as controls.\n\nall studied children will be subjected to careful history taking and through clinical examination. laboratory investigations will be done including complete blood count, hemoglobin electrophoresis, serum ferritin, liver and kidney functions, and troponin-1 plasma level. echocardiographic assessment of the cardiac functions will be done for all patients. Source data will be the patients medical records.\n\noral spirulina will be given for studied patients for 3 months, and clinical examination, laboratory investigations and cardiac functions will be assessed at the time of inclusion in the study, and again after 3 months of regular spirulina supplementation.\n\nAn informed consent will be obtained from parents of all included subjects. the results of this study will be tabulated and statistically analyzed using Statistical Package for the Social Sciences (SPSS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children suffering from beta thalassemia major with age range from 4-18 years\n\nExclusion Criteria:\n\n* children with congenital heart diseases children with rheumatic heart diseases presence of heart failure children with coronary arterial disease children with cardiomyopathy'}, 'identificationModule': {'nctId': 'NCT02597595', 'briefTitle': 'Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major', 'orgStudyIdInfo': {'id': '2771/09/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients', 'description': 'thirty children with beta thalassemia major, with age range from 4-18 years, will receive oral spirulina (tablets=500 mg) for 3 months with a dose of 250 mg/kg/day (maximum dose 4 gm)', 'interventionNames': ['Other: spirulina']}, {'type': 'NO_INTERVENTION', 'label': 'controls', 'description': 'thirty healthy children of matched age and sex'}], 'interventions': [{'name': 'spirulina', 'type': 'OTHER', 'description': 'oral spirulina (tablet=500mg) will be given to patients for 3 months in a dose of 250 mg/kg/day (maximum 4 gm)', 'armGroupLabels': ['patients']}]}, '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': 'Magda M Ibrahim, M.B.B.ch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Master Degree student'}, {'name': 'Osama AR Tolba, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'supervisor'}, {'name': 'Rasha M Gamal, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'supervisor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor and head of hematology and oncology unit at pediatric department', 'investigatorFullName': 'Professor Mohamed Elshanshory', 'investigatorAffiliation': 'Tanta University'}}}}