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

April 1, 2026 updated by: French National Agency for Research on AIDS and Viral Hepatitis

Multicenter Open and Prospective Trial Assessing the Efficacy of Vitamin D Supplementation in Addition to Pegylated Interferon Plus Ribavirin in Null-Responders Patients With Chronic Viral Hepatitis C Genotype 1 or 4

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

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

  • France
      • Paris, France, 75013
        • Hopital Pitie Salpetriere

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Addition of Vitamin D to Peg-interferon plus Ribavirin
Drug: vitamin D
Vitamin D on top of the standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy
Time Frame: at week 12
at week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in HCV viral load after correction of vitamin D deficiency (delta log)
Time Frame: at day 0
at day 0
Changes in HCV viral load (delta log)
Time Frame: at week 4
at week 4
Changes in HCV viral load (delta log)
Time Frame: at week 12
at week 12
Negativity of HCV RNA below 12 UI/ml
Time Frame: at week 24
at week 24
Negativity of HCV RNA below 12 UI/ml
Time Frame: at week 72
at week 72

Collaborators and Investigators

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

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

  • Principal Investigator: Patrice Cacoub, MD, Pitié Salpêtrière hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimated)

October 22, 2010

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS HC 25 VITAVIC
  • 2010-021967-34 (EudraCT Number)

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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