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

Not Applicable

Completed

• Conditions: Beta Thalassemia
• Interventions: Other: spirulina

• Registration Number: NCT02597595
• Lead Sponsor: Tanta University

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).

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-09-05
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients	spirulina	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
cardiac functions measured by troponin-1 plasma level.	after 3 months of regular oral spirulina supplementation

Trial Locations

Locations (1)

Faculty of Medicine- Tanta University; 🇪🇬 Tanta, Gharbia, Egypt