Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- effect of vitamin E on Liver iron concentration (LIC)
研究概览
简要总结
repeated transfusions are the mainstay of disease management in most patients with transfusion dependent beta thalassemia.iron overload predispose to oxidative stress and tissue injury.
oxidative stress play important role in pathogenesis of anemia in beta thalassemia.
vitamin E is often depleted in thalassemia patients.
详细描述
oxidative stress status is very important in thalassemic patients and explains the different manifestations in thalassemic patients.
vitamin E is fat soluble vitamin shown to reduce the oxidative stress in thalassemia and to reduce lipid peroxidation of red cell membranes.
therefore, this study shows the safety of oral vitamin E as adjuvant therapy to three iron chelators : desferoxamine,deferiprone and deferasirox in moderately iron overloaded children and adolescents with transfusion dependent beta thalassemia and its relation to iron overload over one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Beta thalassemia patients on regular packed red blood cells transfusion,with vitamin E deficiency
- •serum ferritin 1000-2500 ug/l
- •cardiacT2*>10ms and ejection fraction >55%
排除标准
- •Diabetes,active hepatitis(serum transaminases >2 times ULN)
- •renal impairment (serum creatinine>2times ULN)
- •participation in previous investigational drug study with 3 months preceding screening supplementation with antioxidants or vitamins within 3 months prior to the study and patients with known allergy to vitamin
结局指标
主要结局
effect of vitamin E on Liver iron concentration (LIC)
时间窗: 12 months
measuring the LIC using MRI (magnetic resonance imaging) in mg/g
次要结局
- effect of vitamin E on antioxidants enzymes(12 months)
- effect of vit E supplementation on SF(12 months)
研究者
Amira Abd el moneam
professor
Ain Shams University