Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients (Addwin)

Hanyang University

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis C

Treatments: Drug: Vit D

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01439776

ML25569

Details and patient eligibility

About

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3 Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral response(SVR)compared to Peg/RBV.

Full description

The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 1-3 patients with chronic HCV infection significantly improves RVR, EVR additionally.

Enrollment: 180 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic genotype 1-3 HCV infection
• Treatment Naive

Exclusion criteria

• Child B and C
• HCC patients
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Peginterferon alfa 2a+Ribavirin

No Intervention group

Description:

standard of care for HCV : peginterferon alfa 2a and ribavirin

Vit D+Peginterferon alfa 2a+Ribavirin

Experimental group

Description:

VitD+Peginterferon alfa 2a+Ribavirin

Treatment:

Drug: Vit D