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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Ziv Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Hillel Yaffe Medical Center
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01146626
First received: June 16, 2010
Last updated: April 27, 2011
Last verified: June 2010
History of Changes
  Purpose

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 Intervention
Hepatitis C
 Drug: Peg+ Vitamin D+ Ribavirine
Drug: Peg+ Ribavirine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • SVR rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    to evaluate the response rate


Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146626

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

No publications provided

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01146626     History of Changes
Other Study ID Numbers: HCV +Vitamin D
Study First Received: June 16, 2010
Last Updated: April 27, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Ziv Hospital:
Vitamin D
Hepatitis C
Genotype2,3
SVR
 Naive
RVR rate
EVR rate
SVR rate

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis A
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013