Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- cardiac functions measured by echocardiography
研究概览
简要总结
The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children suffering from beta thalassemia major with age range from 4-18 years
排除标准
- •children with congenital heart diseases children with rheumatic heart diseases presence of heart failure children with coronary arterial disease children with cardiomyopathy
结局指标
主要结局
cardiac functions measured by echocardiography
时间窗: 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
次要结局
- cardiac functions measured by troponin-1 plasma level.(after 3 months of regular oral spirulina supplementation)
研究者
Professor Mohamed Elshanshory
professor and head of hematology and oncology unit at pediatric department
Tanta University