跳至主要内容
临床试验/NCT02744560
NCT02744560已完成不适用

Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C

Tanta University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
liver iron concentration using magnetic resonance imaging (T2* gradient echo pulse sequence in the axial plane)

研究概览

简要总结

Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Magnetic resonance imaging represents the most available noninvasive technique to assess the level of iron in the liver.there is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.

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
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • multitransfused beta thalassemic children with super added hepatitis C virus (HCV) infection diagnosed by serological detection of HCV antibodies and HCV RNA by polymerase chain reaction.

排除标准

  • liver decompensation child younger than 3 years patients with hepatitis B infection contraindications to perform MRI (intraocular metallic foreign body, cardiac pacemaker, intracranial clips of arterial brain aneurysms) refusal to participate in the study

研究组 & 干预措施

patients

Experimental

30 multitransfused beta thalassemic children infected with hepatitis C virus diagnosed by serological detection of HCV-antibodies and HCV RNA by polymerase chain reaction will be given Spirulina in a dose of 250 mg/kg/day orally for 3 months.

干预措施: spirulina (Dietary Supplement)

结局指标

主要结局

liver iron concentration using magnetic resonance imaging (T2* gradient echo pulse sequence in the axial plane)

时间窗: 3 months

次要结局

未报告次要终点

研究者

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

Professor Mohamed Elshanshory

head of pediatric hematology and oncology unit

Tanta University

研究点 (2)

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