Evaluation of Oxidant Status in Patients With Immune Thrombocytopenia (ITP) and the Role of an Adjuvant Antioxidant Therapy
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- oxidant status in ITP
研究概览
简要总结
Oxidative stress occurs as a result of increased activity of free radical-producing enzymes, decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants. The most sensitive molecules to oxidation are lipids. Loss of cell membrane elasticity, increased cell fragility, and a shortened cellular life span results from oxidation of cell membrane lipids.
详细描述
Free oxygen radicals may have an effect on the structural and functional damage of platelets and plays a role in pathogenesis of thrombocytopenia in both, acute and chronic ITP.
Selenium is an essential mineral found in small amounts in the body. It works as an antioxidant, especially when combined with other antioxidants as vitamin E , A and C. Antioxidants neutralize free radicals and may reduce or even help prevent some of the damage they cause.
aim of this study is to assess oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP) and 6 months later.Another aim of the study is to evaluate effect of antioxidant therapy on bleeding score, platelet count and antioxidant status during 6 months follow-up.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients less than 18 years with primary ITP; at initial presentation with platelet count less than 40 x 109/L attended Ain Shams Hematology clinic Children hospital from January 2013 and followed-up for 6 months.
- •For acute ITP, patients will be newly diagnosed (about one month within the diagnosis).
- •For chronic (12-24 months) and persistent (3-12 months) ITP patients.
排除标准
- •Patients' platelet count more than 40 x 109/L.; or above 18 years
- •Patients with secondary cause for thrombocytopenia.
- •Patients with any there associated chronic illness affecting oxidant status
研究组 & 干预措施
Antioxidant, drug therapy for ITP
interventional arm 1 and will receive antioxidant therapy (Antox tablets ( 1 tablet contains : Vit. A 2000 IU, Vit C 90 mg, Vit E 15 mg and selenium yeast 55 ug ) with the therapy selected for ITP tailored according to patient's presentation.For Antox tablets it will be given daily for 6 months.
干预措施: Antox tablets(Mepaco) (Drug)
Antioxidant, drug therapy for ITP
interventional arm 1 and will receive antioxidant therapy (Antox tablets ( 1 tablet contains : Vit. A 2000 IU, Vit C 90 mg, Vit E 15 mg and selenium yeast 55 ug ) with the therapy selected for ITP tailored according to patient's presentation.For Antox tablets it will be given daily for 6 months.
干预措施: drug therapy for ITP (Other)
drug therapy for ITP
drug therapy for ITP according to ASH, 2011 guidelines.
干预措施: drug therapy for ITP (Other)
结局指标
主要结局
oxidant status in ITP
时间窗: 6 month
oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)
次要结局
- antioxidant therapy(6 months)
研究者
Mohsen Saleh Elalfy
professor of pediatrics
Ain Shams University