Can Vitamin D Supplementation Improve Hepatitis C Cure Rates

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Exclusion criteria are:

• 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