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Completed

NCT Number: NCT01226446

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

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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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hôpital Pitié Salpêtrière

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

Vitamin D on top of the standard treatment

Primary outcomes

  1. Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy

    Time frame: at week 12

Secondary outcomes

  1. Changes in HCV viral load after correction of vitamin D deficiency (delta log)

    Time frame: at day 0

  2. Changes in HCV viral load (delta log)

    Time frame: at week 4

  3. Changes in HCV viral load (delta log)

    Time frame: at week 12

  4. Negativity of HCV RNA below 12 UI/ml

    Time frame: at week 24

  5. Negativity of HCV RNA below 12 UI/ml

    Time frame: at week 72

Sponsors and collaborators

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis

Other Gov

Registry information

Official study title

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

Acronym: ANRS VITAVIC

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Oct 22, 2010
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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