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

Ziv Hospital

Status: Unknown

Conditions: Hepatitis C

Treatments: Drug: Peg+ Ribavirine; Drug: Peg+ Vitamin D+ Ribavirine

Study type: Interventional

Funder types: Other

Identifiers

NCT01146626

HCV +Vitamin D

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Peg+ Vitamin D+ Ribavirine

Active Comparator group

Description:

Peg+ Vitamin D+ Ribavirine

Treatment:

Drug: Peg+ Vitamin D+ Ribavirine

Peg+ Ribavirine

Experimental group

Description:

Peg+ Ribavirine

Treatment:

Drug: Peg+ Ribavirine