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

Study Overview
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Brief Summary
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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 response and shorten treatment duration (from 24 weeks to 12 weeks) whether Vitamin D levels predictes negative treatment outcome.

Detailed Description
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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

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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Peg+ Vitamin D+ Ribavirine
* Drug: Peg+ Ribavirine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peg+ Vitamin D+ Ribavirine<br>Peg+ Vitamin D+ Ribavirine | Drug: Peg+ Vitamin D+ Ribavirine<br>* Peg+ Vitamin D+ Ribavirine<br>|
| Experimental: Peg+ Ribavirine<br>Peg+ Ribavirine | Drug: Peg+ Ribavirine<br>* Peg+ Ribavirine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR rate | to evaluate the response rate | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Hepatitis C, Genotype2,3, SVR, Naive, RVR rate, EVR rate, SVR rate