Long Term Vitamin D Therapy in HCV Treated Patients

Phase 3

Terminated

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Vitamin D

• Registration Number: NCT01997203
• Lead Sponsor: Dr. Nadia AbdelAaty AbdelKader

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-27
• Last Update Submitted: 2013-11-27
• Study First Posted: 2013-11-28
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Chronic HCV infection (positive HCV Ab more than 6 months)
• Treated with pegylated interferon and ribavirin

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCV patients under treatment	Vitamin D	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

Primary Outcome Measures

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

Trial Locations

Locations (2)

Medical biochemistry department, Cairo university; 🇪🇬 Cairo, Egypt

Tropical Medicine department, Bny swif university; 🇪🇬 Bny swif, Egypt