Does Vitamin D Supplement Improve SVR in Chronic Hepatitis C (Genotype 2,3) in naïve Patients Treated With Peginterferon Alpha and Ribavirin
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- SVR rate
研究概览
简要总结
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines
- whether adding vitamin D, a potent immunomodulator, could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
- whether Vitamin D levels predictes negative treatment outcome.
详细描述
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, could improve viral respons.The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 2,3 patients with chronic HCV infection significantly improves RVR, EVR, and SVR
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years of age,
- •Chronic genotype 2,3 HCV infection, Traetment Naive
- •Negative sero for HBV, HDV and HIV viral infections
- •Absolute neutrophil count of >1500 per cubic millimeter, a platelet count of >90,000 per cubic millimeter
- •Normal hemoglobin level
排除标准
- •Decompensated liver disease (cirrhosis with CP score >9)
- •Another cause of clinically significant liver disease
- •Hepato cellular carcinoma
- •Psychiatric Disorder
- •Chronic heart failure
- •Pregnant women
- •Uncontrolled diabetes with retinopathy
- •Active CAD
- •Positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease
研究组 & 干预措施
Peg+ Vitamin D+ Ribavirine
Peg+ Vitamin D+ Ribavirine
干预措施: Peg+ Vitamin D+ Ribavirine (Drug)
Peg+ Ribavirine
Peg+ Ribavirine
干预措施: Peg+ Ribavirine (Drug)
结局指标
主要结局
SVR rate
时间窗: 1 year
to evaluate the response rate
次要结局
未报告次要终点