Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- liver stiffness measurement using transient elastography (Fibroscan)
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. Transient elastography (Fibroscan) is a reliable non invasive method for diagnosing as liver fibrosis in thalassemic patients regardless of the degree of iron overload. 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •multitransfused beta thalassemic children with and without 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 implantable cardiac device failure to obtain transient elastography (Fibroscan) results
研究组 & 干预措施
thalassemic children without hepatitis C
30 multitransfused beta thalassemic children without hepatitis C virus infection
thalassemic children with hepatitis C
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 stiffness measurement using transient elastography (Fibroscan)
时间窗: 3 months
次要结局
- liver function tests(3 months)
- aspartate aminotransferase to platelet ratio index (APRI)(3 months)
研究者
Professor Mohamed Elshanshory
head of pediatric hematology and oncology unit
Tanta University