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

April 27, 2011 updated by: Ziv Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hedera, Israel
        • Liver Clinic
      • Safed, Israel, Israel, 13100
        • Ziv medical center liver unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peg+ Vitamin D+ Ribavirine
Drug: Peg+ Vitamin D+ Ribavirine
Peg+ Vitamin D+ Ribavirine
Experimental: Peg+ Ribavirine
Drug: Peg+ Ribavirine
Peg+ Ribavirine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR rate
Time Frame: 1 year
to evaluate the response rate
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ziv Hospital

Collaborators

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

February 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

June 16, 2010

First Submitted That Met QC Criteria

June 16, 2010

First Posted (Estimate)

June 17, 2010

Study Record Updates

Last Update Posted (Estimate)

April 28, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCV +Vitamin D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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