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Can Vitamin D Supplementation Improve Hepatitis C Cure Rates

NCT02053519 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-10-26

No results posted yet for this study

Summary

Evidence suggests that vitamin D may be directly or indirectly a co-factor for the efficacy of Hepatitis C virus, (HCV), antiviral therapies. The level of vitamin D necessary for optimum immune function is ill defined and many of those with HCV infection in Scotland are below these levels. Vitamin D is a cheap and safe medication, so its addition to anti-viral therapy should be highly cost-effective even if only a modest increase in SVR was achieved. Given the Scottish HCV epidemic, the world leading government response to it and the nationally low vitamin D levels, Scotland is perfectly placed to answer this question. Therefore the investigators hypothesize that vitamin D supplementation will improve SVR and propose a randomised controlled trial to test this hypothesis. The anticipated end of study date for this study is April 2015

Conditions

  • Hepatitis C

Interventions

DRUG

Active Comparator: Vigantol Oil (Vitamin D3)

Vitamin D Oral oil 100.000iu in 5 mls

DRUG

Mygliol Oil

Matched placebo comparator

Sponsors & Collaborators

  • University of Dundee

    lead OTHER

Principal Investigators

  • John Dillon, MD · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-04-30
Completion
2016-10-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02053519 on ClinicalTrials.gov