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

Tanta University

Status: Completed

Conditions: Beta Thalassemia

Treatments: Other: spirulina

Study type: Interventional

Funder types: Other

Identifiers

NCT02597595

2771/09/14

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

patients

Experimental group

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)

Treatment:

Other: spirulina

controls

No Intervention group

Description:

thirty healthy children of matched age and sex