NCT01146626

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ziv Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Peg+ Vitamin D+ Ribavirine	Peg+ Vitamin D+ Ribavirine
DRUG	Peg+ Ribavirine	Peg+ Ribavirine

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-02-01
• Completion: 2012-05-01
• First posted: 2010-06-17
• Last updated: 2011-04-28

Locations

2 sites across 1 country: Israel