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

Hanyang University180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Chronic Hepatitis C

Interventions

Vit DDRUG

800IU/day

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic genotype 1-3 HCV infection * Treatment Naive Exclusion Criteria: * Child B and C * HCC patients * Pregnancy

Locations (13)

Soonchunhyang university Hospital Cheonan

Cheonan, Chungcheongnam-do, South Korea

Soonchunhyang university hospital Bucheon

Bucheon-si, Gyeonggi-do, South Korea

HANYANG University Guri Hospital

Guri-si, Gyeonggido, South Korea

Outcomes

Primary Outcomes

Number of participants with Sustained virologic response (SVR)

Compare the number of participants with HCV RNA is not detected in the blood at 24 weeks post-treatment between vitamin D and control group.

Time frame: 24w after completing Peg/RBV

Secondary Outcomes

Number of participants with End of treatment response (ETR)

Compare the number of participants with HCV RNA is not detected in the blood at the end of treatment between two groups. HCV RNA pCR perform at 48 weeks in genotye 1, at 24 weeks in Genotye 2 and 3

Time frame: 48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3

Number of participants with Rapid virological response (RVR)

Compare the number of participants with HCV RNA is notdetectable in the blood at week 4 of treatment between vitamin and control group

Time frame: Week 4

Number of participants with Early virological response (EVR)

Compare the number of participants with HCV RNA cannot be detected in the blood at week 12 of treatment between viatmin and control group

Time frame: Week 12

Data from ClinicalTrials.gov

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