Can Vitamin D supplementation improve Hepatitis C cure raTes: A pilot multicentre randomised controlled clinical trial. The ViaDUCT Study

Phase 1

• Conditions: Hepatitis C virus; MedDRA version: 14.1Level: PTClassification code 10065051Term: Acute hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-003573-10-GB
• Lead Sponsor: niversity of Dundee & NHS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-30
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

•Have confirmed hepatitis C with positive PCR for genotype 1 or 3
•Are planned to commence on standard eradication therapy for HCV
•Aged 18 or over

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Hepatitis C genotype other than 1 or 3
• Previous treatment with interferon/ribivarin
•Contraindications to interferon / ribavirin therapy
•eGFR <30 ml/min (by MDRD4 method)
•Currently decompensated liver disease
oAscites, encephalopathy or variceal bleeding
•History of renal calculi
•Serum calcium <2.15 mmol/L or >2.60 mmol/L
•History of sarcoidosis, metastatic malignancy
•Hepatocellular carcinoma (current or previous)
•Taking >400 units/day of vitamin D
•HIV positive
•Pregnancy
•Breastfeeding
•Of childbearing potential and not taking reliable contraception
• Participation in another drug trial concurrently or within 30 days of screening for this one
•Unable to provide written informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified