Long Term Vitamin D Therapy in HCV Treated Patients

Chronic Hepatitis C Clinical Trial

— VD-HCV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01997203
• Other study ID #: HCV-VD2013
• Status: Terminated
• Phase: Phase 3
• First received: November 19, 2013
• Last updated: November 27, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: November 2013
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ain Shams University
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Vitamin D
vitamin D was given to 50 patients (HCV under treatment)

Locations

Country	Name	City	State
Egypt	Tropical Medicine department, Bny swif university	Bny swif
Egypt	Medical biochemistry department, Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Nadia AbdelAaty AbdelKader

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy		48 weeks	No