Does Vitamin D Improves Sustained Virologic Response (SVR) in Genotype 2,3 Chronic Hepatitis C Patients?
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ClinicalTrials.gov Identifier: NCT01146626 |
Recruitment Status
: Unknown
Verified June 2010 by Ziv Hospital.
Recruitment status was: Not yet recruiting
First Posted
: June 17, 2010
Last Update Posted
: April 28, 2011
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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 response and shorten treatment duration (from 24 weeks to 12 weeks)
- 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 |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Peg+ Vitamin D+ Ribavirine
Peg+ Vitamin D+ Ribavirine
|
Drug: Peg+ Vitamin D+ Ribavirine
Peg+ Vitamin D+ Ribavirine
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Experimental: Peg+ Ribavirine
Peg+ Ribavirine
|
Drug: Peg+ Ribavirine
Peg+ Ribavirine
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- SVR rate [ Time Frame: 1 year ]to evaluate the response rate

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146626
Contact: Assy Nimer, MD | +97246828445 | assy.n@ziv.health.gov.il |
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 |
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 Key Record Dates |
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 |