Beta Thalassemia
Conditions
Brief summary
The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.
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).
Interventions
OTHERspirulina
oral spirulina (tablet=500mg) will be given to patients for 3 months in a dose of 250 mg/kg/day (maximum 4 gm)
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| cardiac functions measured by troponin-1 plasma level. | after 3 months of regular oral spirulina supplementation |
Countries
Egypt
Outcome results
None listed