Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major

Study Overview
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Brief Summary
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The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.

Detailed Description
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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).

Official Title
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Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major

Conditions
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Beta Thalassemia

Intervention / Treatment
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* Other: spirulina


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br>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<br>* oral spirulina (tablet=500mg) will be given to patients for 3 months in a dose of 250 mg/kg/day (maximum 4 gm)<br>|
| No Intervention: controls<br>thirty healthy children of matched age and sex | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac functions measured by echocardiography | 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 | after 3 months of regular oral spirulina supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac functions measured by troponin-1 plasma level. |  | after 3 months of regular oral spirulina supplementation |