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

Tanta University60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Beta Thalassemia

Interventions

spirulinaOTHER

oral spirulina (tablet=500mg) will be given to patients for 3 months in a dose of 250 mg/kg/day (maximum 4 gm)

Eligibility

Sex: ALLMin age: 4 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, Egypt

Outcomes

Primary Outcomes

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

Time frame: after 3 months of regular oral spirulina supplementation

Secondary Outcomes

cardiac functions measured by troponin-1 plasma level.

Time frame: after 3 months of regular oral spirulina supplementation

Data from ClinicalTrials.gov

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