None listed
Conditions
Brief summary
Currently there is no treatment for the common liver condition NASH. Vitamin D has effects which can act against inflammation and scarring in the liver, which are important in the development of NASH. This study will assess high-dose vitamin D as a treatment for NASH.
Interventions
High-dose oral vitamin D3 (cholecalciferol) in a once weekly dosing form for 24 weeks, initially at 25,000 IU/week, targeting a 25(OH)D level of 100-125 nmol/L. The dose will be titrated upwards or downwards if necessary every 6 weeks, depending on the 25(OH)D level on blood testing performed every 6 weeks.
Sponsors
Dr Matthew Kitson
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
NAFLD Activity Score of 4 or more, with a score of at least 1 point each in steatosis, lobular inflammation and hepatocyte ballooning component scores, on liver biopsy within the previous 3 months.
Exclusion criteria
Alcohol intake of 30g/day or greater in males and 20g/day or greater in females Any contraindication to percutaneous liver biopsy Presence of HBsAg+ or HCV PCR+, or any other cause of liver disease other than NASH Pregnant or breast-feeding Uncontrolled Type 2 Diabetes Mellitus Inability to provide informed consent Cirrhosis Presence of significant cardiovascular or renal disease Corrected calcium >2.60 mmol/L History of nephrolithiasis or sarcoidosis Current therapy with vitamin D, vitamin E, thiazolidinediones, milk thistle, hepatic enzyme inhibitors or with drugs known to cause steatohepatitis
Outcome results
None listed