The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serum ferritin level ( mg/dl)
研究概览
简要总结
The effect of N-acetylcysteine as antioxidant and its effect on pretransfusion hemoglobin and iron overload in patients with thalassemia were compared to patients who didn't receive n-acetylcysteine after 3 months of study duration
详细描述
N-acetylcysteine( NAC) is a widely used mucolytic drug and several studies had reported its efficacy as anti oxidant. Patients with thalassemia major are at great risk for oxidative stress due to excess of b-globin chains and iron overload. In this study the investigators compared the effect of NAC on oxidative status , pretransfusion hemoglobin levels and iron overload in thalassemia patients before and after treatment with NAC for 3 months and with that of patients who served as controls.
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
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thalassemia major children on regular blood transfusion and iron chelation therapy
排除标准
- •Renal or hepatic impairments
- •Complicated thalassemia major
- •Non adherence to therapy or follow up visits
- •Change in the iron chelation dose within 3 months before enrollment or during study period
研究组 & 干预措施
N-acetylcysteine group
Patients received oral n-acetylcysteine syrup on dose of 10 mg/kg/day as single dose for 3 months
干预措施: N-acetyl cysteine (Drug)
结局指标
主要结局
Serum ferritin level ( mg/dl)
时间窗: 3 months
Oxidative stress index (pg/mmol)
时间窗: 3 months
Oxidative stress index is calculated as the ratio of total oxidative status (pg/dl) to total anti oxidative capacity (mmol/dl)
次要结局
未报告次要终点
研究者
Heba Mostafa Ahmed
Assistant Professor
Beni-Suef University