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Trial registered on ANZCTR


Registration number
ACTRN12611001287921
Ethics application status
Approved
Date submitted
12/12/2011
Date registered
15/12/2011
Date last updated
3/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of the impact of high-dose vitamin D supplementation on non-alcoholic steatohepatitis
Scientific title
A pilot study of the impact of high-dose vitamin D supplementation on non-alcoholic steatohepatitis
Secondary ID [1] 273581 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic steatohepatitis 279380 0
Condition category
Condition code
Metabolic and Endocrine 285564 285564 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 283877 0
Treatment: Drugs
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286124 0
2 or more point improvement in NAFLD Activity Score with no worsening of fibrosis on follow up liver biopsy
Timepoint [1] 286124 0
24 weeks
Secondary outcome [1] 295195 0
Resolution of steatohepatitis on follow up liver biopsy
Timepoint [1] 295195 0
24 weeks
Secondary outcome [2] 295196 0
Improvement in steatohepatitis as measured by Brunt score on follow up liver biopsy
Timepoint [2] 295196 0
24 weeks
Secondary outcome [3] 295197 0
Improvement, on follow up liver biopsy, of individual components of the NAFLD Activity Score: steatosis, lobular inflammation, hepatocyte ballooning,
Timepoint [3] 295197 0
24 weeks
Secondary outcome [4] 295198 0
Safety, as defined by lack of adverse events (such as hypercalcaemia) and serious adverse events (such as nephrolithiasis, complication of percutaneous liver biopsy).
Timepoint [4] 295198 0
24 weeks
Secondary outcome [5] 295199 0
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)
Timepoint [5] 295199 0
24 weeks
Secondary outcome [6] 295200 0
Improvement in fibrosis stage on follow up liver biopsy
Timepoint [6] 295200 0
24 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284362 0
Hospital
Name [1] 284362 0
Alfred Hospital
Address [1] 284362 0
55 Commercial Rd
Melbourne
VIC 3004
Country [1] 284362 0
Australia
Primary sponsor type
Individual
Name
Dr Matthew Kitson
Address
Department of Gastroenterology
Alfred Hospital
55 Commercial Rd
Melbourne
VIC 3004
Country
Australia
Secondary sponsor category [1] 283302 0
None
Name [1] 283302 0
Address [1] 283302 0
Country [1] 283302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286322 0
Alfred Hospital HREC
Ethics committee address [1] 286322 0
55 Commercial Rd
Melbourne
VIC 3004
Ethics committee country [1] 286322 0
Australia
Date submitted for ethics approval [1] 286322 0
Approval date [1] 286322 0
28/06/2011
Ethics approval number [1] 286322 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33523 0
Address 33523 0
Country 33523 0
Phone 33523 0
Fax 33523 0
Email 33523 0
Contact person for public queries
Name 16770 0
Dr Matthew Kitson
Address 16770 0
Gastroenterology Department
Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 16770 0
Australia
Phone 16770 0
+61 3 90762223
Fax 16770 0
Email 16770 0
m.kitson@alfred.org.au
Contact person for scientific queries
Name 7698 0
Dr Matthew Kitson
Address 7698 0
Gastroenterology Department
Alfred Hospital
55 Commercial Rd
Melbourne VIC 3004
Country 7698 0
Australia
Phone 7698 0
+61 3 90762223
Fax 7698 0
Email 7698 0
m.kitson@alfred.org.au

No information has been provided regarding IPD availability
Summary results
No Results