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临床试验/NCT03903133
NCT03903133已完成4 期

Endothelial Monocyte-activating Polypeptide-II as an Endothelial Dysfunction Marker and Its Relation to the Oxidative Stress in Egyptian Sickle Patients

Ain Shams University0 个研究点目标入组 50 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
50
主要终点
Oxidative stress markers

研究概览

简要总结

This study objectives to assess the role of endothelial monocyte-activating polypeptide II (EMAP II) as a marker of endothelial dysfunction and disturbed angiogenesis in sickle cell disease and to identify its correlation With the oxidative status.

详细描述

Study design:

Screening/Baselie Phase

  • Detailed medical history with special emphasis on demographic data, transfusion and chelation therapy, disease modifying therapy

  • Thorough clinical examination

  • Laboratory investigations to be done will include:

  • Liver function test

  • Marker of hemolysis

  • Serum ferritin .

  • Complete blood count(CBC)

  • Hemoglobin electrophoresis

  • Determination of serum levels of EMAP II

  • Lipid Peroxidation (Malondialdehyde Concentration.), Superoxide Dismutase activity, Catalase activity, Glutathione Peroxidase activity, Glutathione Reductase activity, Vitamin E concentration, GSH

The patients under investigations will receive vitamin E supplementation for three months

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with sickle cell disease as confirmed by qualitative and quantitative analysis of hemoglobin using high performance liquid chromatography (HPLC) at their steady state.

排除标准

  • Patients with any inflammatory condition within one month prior to enrollment.

研究组 & 干预措施

vitamin E supplementation

Other

vitamin E supplementation for three months (400-600 mg/day) (400 mg/day in those weighed less than 20 kg and 600 mg/day in those weighed at least 20 kg)

干预措施: Vitamin E (Drug)

结局指标

主要结局

Oxidative stress markers

时间窗: Two years

次要结局

  • Endothelial monocyte-activating polypeptide II(Two year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Soliman Elsayed Ebeid, MD

Professor of Pediatrics

Ain Shams University

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