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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01146626
• Other study ID #: HCV +Vitamin D
• Status: Not yet recruiting
• Phase: N/A
• First received: June 16, 2010
• Last updated: April 27, 2011
• Start date: August 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2010
• Source: Ziv Hospital
• Contact: Assy Nimer, MD
• Phone: +97246828445
• Email: assy.n[@]ziv.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peg+ Vitamin D+ Ribavirine
Peg+ Vitamin D+ Ribavirine
• Peg+ Ribavirine
Peg+ Ribavirine

Locations

Country	Name	City	State
Israel	Liver clinic	Hedera
Israel	Ziv medical center liver unit	Safed, Israel

Sponsors (2)

Lead Sponsor	Collaborator
Ziv Hospital	Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR rate	to evaluate the response rate	1 year	No