Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major
Study Details
Study Description
Brief Summary
The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.
this 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.
all 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.
oral 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.
An 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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: patients 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) |
Other: spirulina
oral spirulina (tablet=500mg) will be given to patients for 3 months in a dose of 250 mg/kg/day (maximum 4 gm)
|
| No Intervention: controls thirty healthy children of matched age and sex |
Outcome Measures
Primary Outcome Measures
- cardiac functions measured by echocardiography [after 3 months of regular oral spirulina supplementation]
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
Secondary Outcome Measures
- cardiac functions measured by troponin-1 plasma level. [after 3 months of regular oral spirulina supplementation]
Eligibility Criteria
Criteria
Inclusion Criteria:
- children suffering from beta thalassemia major with age range from 4-18 years
Exclusion Criteria:
- children with congenital heart diseases children with rheumatic heart diseases presence of heart failure children with coronary arterial disease children with cardiomyopathy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine- Tanta University | Tanta | Gharbia | Egypt | 0000 |
Sponsors and Collaborators
- Tanta University
Investigators
- Principal Investigator: Magda M Ibrahim, M.B.B.ch, Master Degree student
- Study Chair: Osama AR Tolba, MD, supervisor
- Study Director: Rasha M Gamal, MD, supervisor
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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 β-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. Erratum in: Circulation. 2013 Sep 24;128(13):e203.
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