Can Vitamin D Supplementation Improve Hepatitis C Cure Rates
ViaDUCT
2 other identifiers
interventional
72
1 country
8
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2014
Typical duration for phase_3
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedFirst Posted
Study publicly available on registry
February 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 26, 2016
October 1, 2016
2.2 years
January 16, 2014
October 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is the number of patients with sustained virologic responses, (SVR), at 12 weeks post standard therapy on Vitamin D3 as compared to placebo
viral response by Polymerase Chain Reaction, (PCR), will be measured at 12 weeks of treatment and then again at 12 months, (24 weeks following treatment) to measure response to treatment and assess in how many participants this is sustained at 24 weeks following treatment, (ie 12 months)
at 12 weeks and at12 months
Secondary Outcomes (1)
Secondary Objectives
Assessed at week 4, week 12 and week 24 of the Clinical Trial
Study Arms (2)
Vigantol Oil, (Vitamin D3)
ACTIVE COMPARATOROral Vigantol Oil 5 mls, (100 000 iu of Vitamin D). First dose at randomisation, 7 -28 days prior to commencing standard Hepatitis C treatment for Hepatitis C Genotypes 1 or 3 . Thereafter monthly with concurrent Hepatitis C treatment.
MyGliol Oil
PLACEBO COMPARATORMatched placebo. Subjects randomised to this arm will take 5 mls of active Placebo, (Mygliol oil), 7 - 28 days prior to commencing active Hepatitis C treatment and thereafter 5 mls monthly concurrent with Hepatitis C treatment for the duration of the study
Interventions
Vitamin D Oral oil 100.000iu in 5 mls
Eligibility Criteria
You may qualify if:
- Participants will be eligible if they
- 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
You may not qualify if:
- Hepatitis C genotype other than 1 or 3
- Contraindications to interferon / ribavirin therapy
- eGFR \<30 ml/min (by MDRD4 method)
- Currently decompensated liver disease
- o Ascites, 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
- Unable to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
NHS Grampian
Aberdeen, AB25 2ZN, United Kingdom
NHS Tayside
Dundee, DD1 9SY, United Kingdom
NHS Lothian
Edinburgh, EH16 4SA, United Kingdom
NHS Lothian
Edinburgh, EH4 2XU, United Kingdom
NHS Forth Valley
Falkirk, FK5 4WR, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G$ 0SF, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, G12 0YN, United Kingdom
NHS Greater Glasgow and Clyde
Paisley, PA2 9PN, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Dillon, MD
University of Dundee
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Hepatology and Gastroenterology
Study Record Dates
First Submitted
January 16, 2014
First Posted
February 3, 2014
Study Start
February 1, 2014
Primary Completion
April 1, 2016
Study Completion
October 1, 2016
Last Updated
October 26, 2016
Record last verified: 2016-10