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

Chronic Hepatitis C Clinical Trial

Official title:

Association of Vitamin D Binding Protein Polymorphisms With Response to Therapy in Chronic Hepatitis C Egyptian Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788682
• Other study ID #: CL (770)
• Status: Completed
• Phase: N/A
• First received: May 27, 2016
• Last updated: July 25, 2016
• Start date: September 2013
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: National Committee for Combating Viral Hepatitis, Egypt:
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Genetic:
• WT+ Diplotype
3 or 4 vitamin D binding protein major alleles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR		72 weeks	No