Effect of Long-term Vitamin D Therapy on IL-6, Visfatin and Hyaluronic Acid in Hepatitis C Virus Patients' Assessment
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy
研究概览
简要总结
Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects. The purpose of this study is to determine the effect of vitamin D on liver affection in such patients.
详细描述
Fifty patients study group administered vit D were compared with 50 patients control group without vit D. The results showed a significant elevation in vit D levels during the time period, and significant reduction on HCV RNA from the 12th wk to reach zero level in 24th wk. Interleukin 6 (IL-6), visfatin and hyaluronic acid levels were reduced significantly to reach normal values. These concentrations reduction by the effect of vit D on HCV indicated the reduction in inflammation, infection and liver cirrhosis and nearly amelioration HCV.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HCV infection (positive HCV Ab more than 6 months)
- •Treated with pegylated interferon and ribavirin
排除标准
- •Coinfection with Hepatitis B or Hepatitis D or Human Immunodeficiency Virus
- •Previous non response to antiviral therapy.
- •Other causes of chronic liver diseases as schistosomiasis, Wilson disease and alcoholic liver disease.
研究组 & 干预措施
HCV patients under treatment
Fifty patients study group administered vitamin D were compared with 50 patients control group without vitamin D.
Dose of vitamin D 15,000 IU/week
干预措施: Vitamin D (Drug)
结局指标
主要结局
composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy
时间窗: 48 weeks
次要结局
未报告次要终点
研究者
Dr. Nadia AbdelAaty AbdelKader
Ass. prof. Tropical Medicine - Ain Shams University
Ain Shams University