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

Can Vitamin D supplementation improve Hepatitis C cure rates: A pilot multicentre randomised controlled clinical trial - The ViaDUCT study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003573-10-GB

Enrollment

160

Registered

2013-09-30

Start date

2013-11-07

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C virus MedDRA version: 14.1 Level: PT Classification code 10065051 Term: Acute hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Vigantol Oil Product Name: Cholecalciferol Pharmaceutical Form: Oral liquid INN or Proposed INN: (5Z,7E)-9,10-Secocholesta-5,7,10(19)-trien-3ß-ol CAS Number: 67-97-0 Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: • Hepatitis C genotype other than 1 or 3 • Previous treatment with interferon/ribivarin • Contraindications to interferon / ribavirin therapy • eGFR 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to test if vitamin D supplementation improves the chances of standard treatment for HCV infection being effective. To test this we will measure if there is an improvement in the virologic response - ie the level of virus in the blood, 12 weeks after completion of treatment. ;Secondary Objective: • To determine the proportion of patients with rapid virological response (RVR is defined as negative viral load after only 4 weeks of therapy) • To determine the proportion of eligible patients undergoing standard therapy for HCV infection who consent to the study and the drop out rate from therapy of those who consent as compared to those who do not consent in order to establish if a larger multi centre trial to follow this one is feasible. • To determine the proportion of patients with sustained virologic response (SVR) at 24 weeks. (A SVR is defined as undetectable viral load 24 weeks after cessation of therapy). • To determine the impact on the immune system of supplementation with Vitamin D3 as measured by immune markers in the blood. • To determine the effect of supplementation with Vitamin D on adherence to standard HCV therapy. • To establish the cost effectiveness of the Vitamin D intervention modelled on treating all and treating those deficient on testing. ;Primary end point(s): To determine the proportion of patients with sustained virologic response (SVR) at 12 weeks post standard therapy on Vitamin D3 as compared to placebo. ;Timepoint(s) of evaluation of this end point: 9 month visit	—

Measure

Time frame

Main Objective: The primary objective is to test if vitamin D supplementation improves the chances of standard treatment for HCV infection being effective. To test this we will measure if there is an improvement in the virologic response - ie the level of virus in the blood, 12 weeks after completion of treatment. ;Secondary Objective: • To determine the proportion of patients with rapid virological response (RVR is defined as negative viral load after only 4 weeks of therapy) • To determine the proportion of eligible patients undergoing standard therapy for HCV infection who consent to the study and the drop out rate from therapy of those who consent as compared to those who do not consent in order to establish if a larger multi centre trial to follow this one is feasible. • To determine the proportion of patients with sustained virologic response (SVR) at 24 weeks. (A SVR is defined as undetectable viral load 24 weeks after cessation of therapy). • To determine the impact on the immune system of supplementation with Vitamin D3 as measured by immune markers in the blood. • To determine the effect of supplementation with Vitamin D on adherence to standard HCV therapy. • To establish the cost effectiveness of the Vitamin D intervention modelled on treating all and treating those deficient on testing. ;Primary end point(s): To determine the proportion of patients with sustained virologic response (SVR) at 12 weeks post standard therapy on Vitamin D3 as compared to placebo. ;Timepoint(s) of evaluation of this end point: 9 month visit

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Secondary

Measure	Time frame
Secondary end point(s): 1) To determine the proportion of patients with rapid virological response (RVR is defined as negative HCV PCR at 4 weeks of therapy) and who therefore receive response guided shortened therapy. 2) To determine the proportion of eligible patients undergoing standard therapy for HCV infection who consent to the study and the drop out rate from therapy of those who consent as compared to those who do not consent. 3) To determine the proportion of patients with sustained virologic response (SVR) at 24 weeks. (A SVR is defined as undetectable HCV RNA 24 weeks after cessation of therapy. If this is not available a surrogate of undetectable HCV RNA at greater than 12 weeks after cessation of therapy will be used). 4). To determine the impact on the immune system of supplementation with Vitamin D3 as measured by immune markers. 5)To determine the effect of supplementation with Vitamin D3 on adherence to standard HCV therapy. 6) To establish the cost effectiveness of the Vitamin D intervention modelled on treating all and treating those deficient on testing. ;Timepoint(s) of evaluation of this end point: 1)- 1 month 2)- 2.5 year (at study end post LPLV) 3)-12 month 4)-12 month 5)-12 month 6) - 1.5 year (at study end post LPLV)	—

Measure

Time frame

Secondary end point(s): 1) To determine the proportion of patients with rapid virological response (RVR is defined as negative HCV PCR at 4 weeks of therapy) and who therefore receive response guided shortened therapy. 2) To determine the proportion of eligible patients undergoing standard therapy for HCV infection who consent to the study and the drop out rate from therapy of those who consent as compared to those who do not consent. 3) To determine the proportion of patients with sustained virologic response (SVR) at 24 weeks. (A SVR is defined as undetectable HCV RNA 24 weeks after cessation of therapy. If this is not available a surrogate of undetectable HCV RNA at greater than 12 weeks after cessation of therapy will be used). 4). To determine the impact on the immune system of supplementation with Vitamin D3 as measured by immune markers. 5)To determine the effect of supplementation with Vitamin D3 on adherence to standard HCV therapy. 6) To establish the cost effectiveness of the Vitamin D intervention modelled on treating all and treating those deficient on testing. ;Timepoint(s) of evaluation of this end point: 1)- 1 month 2)- 2.5 year (at study end post LPLV) 3)-12 month 4)-12 month 5)-12 month 6) - 1.5 year (at study end post LPLV)

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Countries

United Kingdom

Contacts

Public ContactStephen McSwiggan

University of Dundee, Tayside Clinical Trials Unit

s.j.mcswiggan@dundee.ac.uk01382383233

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026