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CompletedNCT01226446ANRS VITAVICUpdated Apr 6, 2026

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

A Phase 2 interventional study of vitamin D in Chronic Hepatitis C, sponsored by French National Agency for Research on AIDS and Viral Hepatitis. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by French National Agency for Research on AIDS and Viral Hepatitis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

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Conditions studied

  • Chronic Hepatitis C
03

In context

Hepatitis C, Chronic

1,073 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.

This study's enrollment of 32 is below the median of 90 across 775 interventional studies indexed under Hepatitis C, Chronic.

Browse Hepatitis C, Chronic studies →

Lead sponsor

French National Agency for Research on AIDS and Viral Hepatitis is the lead sponsor of 83 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Addition of Vitamin D to Peg-interferon plus Ribavirin

    Drug: vitamin D

Interventions

  • Drugvitamin D

    Vitamin D on top of the standard treatment

06

What researchers measure

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

07

Study locations

1 site
  • Hôpital Pitié Salpêtrière
    Paris, 75013, France
08

References and documents

Publications

  • Terrier B, Lapidus N, Pol S, Serfaty L, Ratziu V, Asselah T, Thibault V, Souberbielle JC, Carrat F, Cacoub P. Vitamin D in addition to peg-interferon-alpha/ribavirin in chronic hepatitis C virus infection: ANRS-HC25-VITAVIC study. World J Gastroenterol. 2015 May 14;21(18):5647-53. doi: 10.3748/wjg.v21.i18.5647. PubMed 25987791 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01226446
Lead sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Responsible party
Sponsor
First posted
Oct 22, 2010
Start date
Nov 2010
Primary completion
Feb 2012
Completion
Jan 2013
Last update
Apr 6, 2026

Study contacts

Patrice Cacoub, MD
principal investigator · Pitié Salpétrière Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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