Does Vitamin D Improves Sustained Virologic Response (SVR) in Genotype 2,3 Chronic Hepatitis C Patients?

Does Vitamin D Supplement Improve SVR in Chronic Hepatitis C (Genotype 2,3) in naïve Patients Treated With Peginterferon Alpha and Ribavirin

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01146626

Enrollment

Registered

2010-06-17

Start date

2011-08-31

Completion date

2012-05-31

Last updated

2011-04-28

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

Conditions

Hepatitis C

Keywords

Vitamin D, Hepatitis C, Genotype2,3, SVR, Naive, RVR rate, EVR rate, SVR rate

Brief summary

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines 1. whether adding vitamin D, a potent immunomodulator, could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks) 2. whether Vitamin D levels predictes negative treatment outcome.

Detailed description

Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, could improve viral respons.The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 2,3 patients with chronic HCV infection significantly improves RVR, EVR, and SVR

Interventions

DRUGPeg+ Vitamin D+ Ribavirine

Peg+ Vitamin D+ Ribavirine

DRUGPeg+ Ribavirine

Peg+ Ribavirine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 18 to 65 years of age, * Chronic genotype 2,3 HCV infection, Traetment Naive * Negative sero for HBV, HDV and HIV viral infections * Absolute neutrophil count of \>1500 per cubic millimeter, a platelet count of \>90,000 per cubic millimeter * Normal hemoglobin level

Exclusion criteria

* Decompensated liver disease (cirrhosis with CP score \>9) * Another cause of clinically significant liver disease * Hepato cellular carcinoma * Psychiatric Disorder * Chronic heart failure * Pregnant women * Uncontrolled diabetes with retinopathy * Arythmia * Active CAD * Positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease

Design outcomes

Primary

Measure	Time frame	Description
SVR rate	1 year	to evaluate the response rate

Countries

Israel

Contacts

Primary ContactAssy Nimer, MD

assy.n@ziv.health.gov.il+97246828445

Outcome results

None listed

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