Does Vitamin D Improves Sustained Virologic Response (SVR) in Genotype 2,3 Chronic Hepatitis C Patients?

Hepatitis C Clinical Trial

Official title: Does Vitamin D Supplement Improve SVR in Chronic Hepatitis C (Genotype 2,3) in naïve Patients Treated With Peginterferon Alpha and Ribavirin

Status Not yet recruiting

Clinical Trial Summary

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

1. whether adding vitamin D, a potent immunomodulator, could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)

2. whether Vitamin D levels predictes negative treatment outcome.

Clinical Trial Description

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 ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

• NCT number: NCT01146626
• Study type: Interventional
• Source: Ziv Hospital
• Contact: Assy Nimer, MD
• Phone: +97246828445
• Email: assy.n@ziv.health.gov.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2011
• Completion date: May 2012