A pilot study of the impact of high-dose vitamin D supplementation on non-alcoholic steatohepatitis

Phase 2

Not yet recruiting

Conditions: on-alcoholic steatohepatitis
Non-alcoholic steatohepatitis
Metabolic and Endocrine - Metabolic disorders

Registration Number: ACTRN12611001287921

Lead Sponsor: Dr Matthew Kitson

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2 or more point improvement in NAFLD Activity Score with no worsening of fibrosis on follow up liver biopsy[24 weeks]

Secondary Outcome Measures

Name	Time	Method
Resolution of steatohepatitis on follow up liver biopsy[24 weeks];Improvement in steatohepatitis as measured by Brunt score on follow up liver biopsy[24 weeks];Improvement, on follow up liver biopsy, of individual components of the NAFLD Activity Score: steatosis, lobular inflammation, hepatocyte ballooning,[24 weeks];Safety, as defined by lack of adverse events (such as hypercalcaemia) and serious adverse events (such as nephrolithiasis, complication of percutaneous liver biopsy).[24 weeks];Improvement in ALT (a liver function test assessing inflammatory activity in the liver) and HOMA-IR score (a measure of insulin resistance on blood testing)[24 weeks];Improvement in fibrosis stage on follow up liver biopsy[24 weeks]