Efficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-01-31

Brief Summary

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Vitamin D deficiency is commonly found in patients with chronic hepatitis C. The investigators hypothesize that the correction of hypovitaminosis D before the initiation of anti-HCV combination therapy and the maintenance of an optimal vitamin D status during antiviral therapy could improve the antiviral efficacy

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Detailed Description

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An open-label, prospective evaluation of the efficacy of vitamin D supplementation starting 1 month before and continuing for the duration of combination therapy with pegylated interferon alpha (2a or 2b) plus ribavirin in patients with chronic viral hepatitis C genotype 1 or 4, nonresponders to a first antiviral therapy.Vitamin D supplementation is started one month before antiviral therapy in order to introduce pegylated interferon plus ribavirin in patients with optimal vitamin D status

Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Addition of Vitamin D to Peg-interferon plus Ribavirin

Group Type EXPERIMENTAL

vitamin D

Intervention Type DRUG

Vitamin D on top of the standard treatment

Interventions

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vitamin D

Vitamin D on top of the standard treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic Hepatitis C Genotype 1 or 4
* Hypovitaminosis D defined by a value \<30 ng / ml
* Patient non responder to previous antiviral combination therapy of Pegylated Interferon and Ribavirin defined by a decrease in viral load \<2 log at week 12 of the first course (Peg/RBV)
* Patient who received at least 80% of the optimal dose of Pegylated Interferon and Ribavirin according to current recommendations
* Patient for which the investigating physician decided to initiate treatment for hepatitis C combination therapy

Exclusion Criteria

* Decompensated liver disease: Child-Pugh B\> 8 or one of the following criteria: bilirubin\> 35 micromol/L, TP \<50%, ascites, recurrent encephalopathy
* Positive serology for HBV and HIV
* Alcohol consumption exceeding 50 g/day
* Chronic intake of vitamin D
* Thrombocytopenia \<50 000/mm ³, neutropenia \<750/mm ³, hemoglobin \<11 g/dL
* Pregnant women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No