NCT01655966

Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c

Vitamin D in Addition to Pegylated Interferon and Ribavirin Compared to Pegylated Interferon and Ribavirin Alone in the Treatment of Chronic Hepatitis C Genotype 4.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4. Conventional standard of care treatment has modest response with only 50% sustained virologic response. Recent reports have suggested an augmented response with the addition of vitamin D. This is a prospective randomized trial to assess the effectiveness of adding vitamin D to standard of care for chronic hepatitis C genotype 4.

Conditions

• Chronic Hepatitis c

Interventions

Type	Name	Description
DRUG	vitamin D +pegylated interferon + ribavirin	Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks
DRUG	pegylated interferon + ribavirin	pegylated interferon 160ug once weekly Ribavirin (\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-02-01
• Completion: 2014-04-01
• First posted: 2012-08-02
• Last updated: 2014-01-29

Locations

1 site across 1 country: Egypt