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

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ClinicalTrials.gov Identifier: NCT02788682
Recruitment Status : Completed
First Posted : June 2, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Sayed Kamel, 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.


Condition or disease Intervention/treatment
Chronic Hepatitis C Genetic: WT+ Diplotype

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Study Type : Observational
Actual Enrollment : 162 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Vitamin D Binding Protein Polymorphisms With Response to Therapy in Chronic Hepatitis C Egyptian Patients
Study Start Date : September 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort Intervention/treatment
Patients
WT+ Diplotype
Genetic: WT+ Diplotype
3 or 4 vitamin D binding protein major alleles

Controls
WT- Diplotype



Primary Outcome Measures :
  1. SVR [ Time Frame: 72 weeks ]

Biospecimen Retention:   Samples With DNA
EDTA blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic Hepatitis C patients in Egypt
Criteria

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.
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Responsible Party: Ahmed Mohamed Sayed Kamel, Teaching Assistant, Cairo University
ClinicalTrials.gov Identifier: NCT02788682    
Other Study ID Numbers: CL (770)
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ahmed Mohamed Sayed Kamel, Cairo University:
VDBP
single nucleotide polymorphisms (SNPs)
interferon based therapy
Egypt
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections