NCT01226446

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Interventions

Type	Name	Description
DRUG	vitamin D	Vitamin D on top of the standard treatment

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-02-01
• Completion: 2013-01-01
• First posted: 2010-10-22
• Last updated: 2026-04-06

Locations

1 site across 1 country: France