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

Not Applicable

• Conditions: Hepatitis C
• Interventions: Drug: Peg+ Vitamin D+ Ribavirine; Drug: Peg+ Ribavirine

• Registration Number: NCT01146626
• Lead Sponsor: Ziv Hospital

Brief 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

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Last Update Submitted: 2011-04-27
• Last Update Posted: 2011-04-28
• Study Start: 2011-08
• Primary Completion: 2012-02
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Arythmia
• Active CAD
• Positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peg+ Vitamin D+ Ribavirine	Peg+ Vitamin D+ Ribavirine	Peg+ Vitamin D+ Ribavirine
Peg+ Ribavirine	Peg+ Ribavirine	Peg+ Ribavirine

Primary Outcome Measures

Name	Time	Method
SVR rate	1 year	to evaluate the response rate

Trial Locations

Locations (2)

Ziv medical center liver unit; 🇮🇱 Safed, Israel, Israel

Liver clinic; 🇮🇱 Hedera, Israel