Long Term Vitamin D Therapy in HCV Treated Patients (VD-HCV)

November 27, 2013 updated by: Dr. Nadia AbdelAaty AbdelKader

Effect of Long-term Vitamin D Therapy on IL-6, Visfatin and Hyaluronic Acid in Hepatitis C Virus Patients' Assessment

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Bny swif, Egypt
        • Tropical Medicine department, Bny swif university
      • Cairo, Egypt
        • Medical biochemistry department, Cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCV patients under treatment

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
Drug: Vitamin D
vitamin D was given to 50 patients (HCV under treatment)
Other Names:
  • ribavirin
  • pegylated interferon
No Intervention: HCV without Vit D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Nadia AbdelAaty AbdelKader

Investigators

  • Principal Investigator: Dina Sabry, Medical biochemistry, Cairo university
  • Study Chair: Mohamed M Tawfic, Tropical Medicine department, Bny swif university
  • Study Chair: Yehia M Korriem, Tropical Medicine department, Bny swif university
  • Study Chair: Nadia A Abdelkader, Tropical Medicine department, Ain Shams university
  • Study Chair: Amany Y Elkazaz, Medical Biochemistry, faculty of Medicine Suez Canal University
  • Study Chair: Mohamed Ghussin, Biochemistry department, faculty of Pharmacology Ghazza University.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 27, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCV-VD2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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