Chronic Hepatitis CPhase 2ANRS VITAVICNCT01226446
Efficacy of Vitamin D on Top of Pegylated Interferon and Ribavirin in Patients With Chronic Viral Hepatitis C Null-Responders
A Phase 2 study testing vitamin D in people with Chronic Hepatitis C, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Conditions
- Chronic Hepatitis C
- Being tested
- vitamin D
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDrug
Vitamin D on top of the standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Addition of Vitamin D to Peg-interferon plus Ribavirin | Experimental | Not described Receives: Drug: vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy
Measured: at week 12
Secondary outcomes (5)
Changes in HCV viral load after correction of vitamin D deficiency (delta log)
Measured: at day 0
Changes in HCV viral load (delta log)
Measured: at week 4
Changes in HCV viral load (delta log)
Measured: at week 12
Negativity of HCV RNA below 12 UI/ml
Measured: at week 24
Negativity of HCV RNA below 12 UI/ml
Measured: at week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Patrice Cacoub, MD, Principal investigator, Pitié Salpétrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226446
- Sponsor's protocol ID
- ANRS HC 25 VITAVIC
- Other IDs
- 2010-021967-34
- Acronym
- ANRS VITAVIC
- Status last verified
- Jun 2012
- First submitted
- 20 Oct 2010
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01226446
- Acronym / sponsor ID
- ANRS VITAVIC / ANRS HC 25 VITAVIC
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Addition of Vitamin D to Peg-interferon plus Ribavirin | Experimental | Drug: vitamin D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin DVitamin D on top of the standard treatment | Drug | Addition of Vitamin D to Peg-interferon plus Ribavirin |
Primary outcome
Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy
Time frame: at week 12
5 secondary outcomes
Changes in HCV viral load after correction of vitamin D deficiency (delta log)
Time frame: at day 0
Changes in HCV viral load (delta log)
Time frame: at week 4
Changes in HCV viral load (delta log)
Time frame: at week 12
Negativity of HCV RNA below 12 UI/ml
Time frame: at week 24
Negativity of HCV RNA below 12 UI/ml
Time frame: at week 72
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 25987791Terrier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Cacoub, MD principal investigator
Pitié Salpétrière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vitamin D in people with Chronic Hepatitis C, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negativity of HCV RNA below 12UI/mL after 12 weeks of antiviral combination therapy (time frame: at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.