Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Genetic: WT+ Diplotype

• Registration Number: NCT02788682
• Lead Sponsor: Cairo University

Brief Summary

Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response and is associated with clinical progression of many diseases. Our aim is to assess influence of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs), rs4588 (C\>A) and rs7041 (G\>T), on baseline clinical parameters and response to interferon based therapy in chronic Hepatitis C patients in Egypt.

Methodology: Genotyping will be performed by RFLP (Restriction Fragment Length Polymorphism) in treatment naïve Hepatitis C patients and healthy controls. Vitamin D levels will be assessed by ELISA. HCV RNA quantification will be performed by PCR to assess therapy outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2016-05-27
• Study First Submitted QC: 2016-06-01
• Study First Posted: 2016-06-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Age ≥ 18 years and ≤ 60 years, fasting blood sugar less than 115 mg/dl or 20% upper normal limit (140 mg/dl), HBA1C ≤ 7.5% in diabetic patients, normal serum creatinine, normal thyroid stimulating hormone level, negative Hepatitis B surface antigen, hemoglobin ≥ 12g/dl for male or ≥ 11g/dl for female, total leukocytes ≥ 3,500/mm3, ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, presence of HCV RNA by PCR and elevated liver enzymes within the preceding 6 months for patients with F1 fibrosis stage.

Exclusion Criteria

• hypersensitivity to interferon or ribavirin, decompensated liver cirrhosis (presence of ascites, esophageal varices or hepatic encephalopathy), hepatocellular carcinoma, body mass index>35 Kg/m2 and vitamin D supplementation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	WT+ Diplotype	WT+ Diplotype

Primary Outcome Measures

Name	Time	Method
SVR	72 weeks