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

A Randomized, Multi-center, Phase IV Open-label Study Evaluating the Antiviral Efficacy of Addition of Vitamin D in Patients With Treatment Naïve Chronic Hepatitis C Receiving Peginterferon Alfa-2a Plus Ribavirin

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01439776

Acronym

Addwin

Enrollment

180

Registered

2011-09-23

Start date

2011-09-30

Completion date

2018-01-20

Last updated

2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

chronic hepatitis C, SVR, Vit D, Peginterferon alfa 2a, Ribavirin

Brief summary

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.

Detailed 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.

Interventions

DRUGVit D

800IU/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

Vitamin D add

Intervention model description

Control: Peg-ING + ribavirin Treatment: peg-INF+ ribavirin + Vitamin D

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Chronic genotype 1-3 HCV infection * Treatment Naive

Exclusion criteria

* Child B and C * HCC patients * Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with Sustained virologic response (SVR)	24w after completing Peg/RBV	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.

Secondary

Measure	Time frame	Description
Number of participants with End of treatment response (ETR)	48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3	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
Number of participants with Rapid virological response (RVR)	Week 4	Compare the number of participants with HCV RNA is notdetectable in the blood at week 4 of treatment between vitamin and control group
Number of participants with Early virological response (EVR)	Week 12	Compare the number of participants with HCV RNA cannot be detected in the blood at week 12 of treatment between viatmin and control group

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026