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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hepatitis C	Drug: Peg+ Vitamin D+ Ribavirine; Drug: Peg+ Ribavirine	Not Applicable

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

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Does Vitamin D Supplement Improve SVR in Chronic Hepatitis C (Genotype 2,3) in naïve Patients Treated With Peginterferon Alpha and Ribavirin
Study Start Date :	August 2011
Estimated Primary Completion Date :	February 2012
Estimated Study Completion Date :	May 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Peg+ Vitamin D+ Ribavirine; Peg+ Vitamin D+ Ribavirine	Drug: Peg+ Vitamin D+ Ribavirine; Peg+ Vitamin D+ Ribavirine
Experimental: Peg+ Ribavirine; Peg+ Ribavirine	Drug: Peg+ Ribavirine; Peg+ Ribavirine

Outcome Measures

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Primary Outcome Measures :

1. SVR rate [ Time Frame: 1 year ]
   to evaluate the response rate

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Assy Nimer, MD	+97246828445	assy.n@ziv.health.gov.il

Locations

Israel
Liver clinic	Not yet recruiting
Hedera, Israel
Contact: Saif Abu Much, MD
Ziv medical center liver unit	Not yet recruiting
Safed, Israel, Israel, 13100
Contact: Nimer Assy, MD +972-46828445 assy.n@ziv.health.gov.il

Sponsors and Collaborators

Ziv Hospital

Hillel Yaffe Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier:	NCT01146626 History of Changes
Other Study ID Numbers:	HCV +Vitamin D
First Posted:	June 17, 2010
Last Update Posted:	April 28, 2011
Last Verified:	June 2010

Keywords provided by Ziv Hospital:

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

Additional relevant MeSH terms:

Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Flaviviridae Infections	Vitamins; Vitamin D; Ergocalciferols; Ribavirin; Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents