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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

June 16, 2010
April 27, 2011
August 2011
February 2012   (final data collection date for primary outcome measure)
SVR rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
to evaluate the response rate
Same as current
Complete list of historical versions of study NCT01146626 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Does Vitamin D Improves Sustained Virologic Response (SVR) in Genotype 2,3 Chronic Hepatitis C Patients?
Does Vitamin D Supplement Improve SVR in Chronic Hepatitis C (Genotype 2,3) in naïve Patients Treated With Peginterferon Alpha and Ribavirin

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.

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
  • Drug: Peg+ Vitamin D+ Ribavirine
    Peg+ Vitamin D+ Ribavirine
  • Drug: Peg+ Ribavirine
    Peg+ Ribavirine
  • Active Comparator: Peg+ Vitamin D+ Ribavirine
    Peg+ Vitamin D+ Ribavirine
    Intervention: Drug: Peg+ Vitamin D+ Ribavirine
  • Experimental: Peg+ Ribavirine
    Peg+ Ribavirine
    Intervention: Drug: Peg+ Ribavirine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
May 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Assy Nimer, MD +97246828445 assy.n@ziv.health.gov.il
Israel
 
NCT01146626
HCV +Vitamin D
No
Liver Clinic, Ziv medical center
Ziv Hospital
Hillel Yaffe Medical Center
Not Provided
Ziv Hospital
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP