Long Term Vitamin D Therapy in HCV Treated Patients

NCT01997203 | Terminated Phase 3 DMC

• 1 other identifier: HCV-VD2013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Hepatitis C

Keywords

hepatitis C infection; vitamin D

Outcome Measures

Primary Outcomes (1)

• composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy

  48 weeks

Study Arms (2)

HCV patients under treatment

EXPERIMENTAL

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

HCV without Vit D

NO INTERVENTION

Interventions

Vitamin D DRUG

vitamin D was given to 50 patients (HCV under treatment)

Also known as: pegylated interferon, ribavirin

HCV patients under treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Nadia AbdelAaty AbdelKader: lead

Study Sites (2)

Tropical Medicine department, Bny swif university

Bny Swif, Bny Swif, Egypt

Location

Medical biochemistry department, Cairo university

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Vitamin D; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Dina Sabry

  Medical biochemistry, Cairo university

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ass. prof. Tropical Medicine - Ain Shams University

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 28, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

EG (2)