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
Recruitment status was Not yet recruiting
Sponsor:
Ziv Hospital
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
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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
- 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 | 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:
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 (Adult) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146626
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
| 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 Vitamins Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 30, 2016