Back to resultsLong Term Vitamin D Therapy in HCV Treated Patients (VD-HCV)
Primary Purpose
Chronic Hepatitis C
Status
Terminated
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring hepatitis C infection, vitamin D
Eligibility Criteria
Inclusion Criteria:
- Chronic HCV infection (positive HCV Ab more than 6 months)
- Treated with pegylated interferon and ribavirin
Exclusion Criteria:
- Coinfection with Hepatitis B or Hepatitis D or Human Immunodeficiency Virus
- Previous non response to antiviral therapy.
- Other causes of chronic liver diseases as schistosomiasis, Wilson disease and alcoholic liver disease.
Sites / Locations
- Tropical Medicine department, Bny swif university
- Medical biochemistry department, Cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HCV patients under treatment
HCV without Vit D
Arm Description
Fifty patients study group administered vitamin D were compared with 50 patients control group without vitamin D. Dose of vitamin D 15,000 IU/week
Outcomes
Primary Outcome Measures
composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT01997203
First Posted
November 19, 2013
Last Updated
November 27, 2013
Sponsor
Dr. Nadia AbdelAaty AbdelKader
1. Study Identification
Unique Protocol Identification Number
NCT01997203
Brief Title
Long Term Vitamin D Therapy in HCV Treated Patients
Acronym
VD-HCV
Official Title
Effect of Long-term Vitamin D Therapy on IL-6, Visfatin and Hyaluronic Acid in Hepatitis C Virus Patients' Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
complete patients samples required
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Nadia AbdelAaty AbdelKader
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects. The purpose of this study is to determine the effect of vitamin D on liver affection in such patients.
Detailed Description
Fifty patients study group administered vit D were compared with 50 patients control group without vit D. The results showed a significant elevation in vit D levels during the time period, and significant reduction on HCV RNA from the 12th wk to reach zero level in 24th wk. Interleukin 6 (IL-6), visfatin and hyaluronic acid levels were reduced significantly to reach normal values. These concentrations reduction by the effect of vit D on HCV indicated the reduction in inflammation, infection and liver cirrhosis and nearly amelioration HCV.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
hepatitis C infection, vitamin D
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HCV patients under treatment
Arm Type
Experimental
Arm Description
Fifty patients study group administered vitamin D were compared with 50 patients control group without vitamin D.
Dose of vitamin D 15,000 IU/week
Arm Title
HCV without Vit D
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
pegylated interferon, ribavirin
Intervention Description
vitamin D was given to 50 patients (HCV under treatment)
Primary Outcome Measure Information:
Title
composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic HCV infection (positive HCV Ab more than 6 months)
Treated with pegylated interferon and ribavirin
Exclusion Criteria:
Coinfection with Hepatitis B or Hepatitis D or Human Immunodeficiency Virus
Previous non response to antiviral therapy.
Other causes of chronic liver diseases as schistosomiasis, Wilson disease and alcoholic liver disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Sabry
Organizational Affiliation
Medical biochemistry, Cairo university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed M Tawfic
Organizational Affiliation
Tropical Medicine department, bny swif university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yehia M Korriem
Organizational Affiliation
Tropical Medicine department, bny swif university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nadia A Abdelkader
Organizational Affiliation
Tropical Medicine department, Ain Shams university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amany Y Elkazaz
Organizational Affiliation
Medical Biochemistry, faculty of Medicine Suez Canal University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohamed Ghussin
Organizational Affiliation
Biochemistry department, faculty of Pharmacology Ghazza University.
Official's Role
Study Chair
Facility Information:
Facility Name
Tropical Medicine department, Bny swif university
City
Bny swif
Country
Egypt
Facility Name
Medical biochemistry department, Cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Long Term Vitamin D Therapy in HCV Treated Patients
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