Back to resultsEvaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Phlebotomy
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Non-alcoholic fatty liver disease, liver fibrosis, metabolic syndrome, iron overload, phlebotomy
Eligibility Criteria
Inclusion Criteria:
- Patients 18y or older
- Diagnosis of Non-alcoholic Fatty Liver Disease
Exclusion Criteria:
- Unable or unwilling to provide informed consent
- Alcohol consumption of >10g/day for women and >20g/day for men
Sites / Locations
- London Health Sciences Centre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
treatment
Arm Description
Iron depletion via phlebotomy
Outcomes
Primary Outcome Measures
Severity of liver disease
Secondary Outcome Measures
Severity of metabolic disease
Full Information
NCT ID
NCT00641524
First Posted
March 17, 2008
Last Updated
May 12, 2016
Sponsor
University of Western Ontario, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00641524
Brief Title
Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease
Official Title
Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Western Ontario, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the use of phlebotomy (blood taking)as a treatment for patients with non-alcoholic fatty liver disease.
Detailed Description
In this study phlebotomy will be evaluated as a therapy for non-alcoholic fatty liver disease (NAFLD), a common and important cause of liver disease. Phlebotomy has been used for many years in the treatment of disorders of iron overload such as hemochromatosis, where it is well tolerated and improves symptoms and survival. There is some evidence that it is also effective in treating NAFLD. However, previous studies have not evaluated whether phlebotomy improves liver biopsy findings. We will measure the severity disease in NAFLD patients prior to phlebotomy therapy and again at the end of treatment. This will allow us to accurately determine the benefit of this therapy in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
Non-alcoholic fatty liver disease, liver fibrosis, metabolic syndrome, iron overload, phlebotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Other
Arm Description
Iron depletion via phlebotomy
Intervention Type
Procedure
Intervention Name(s)
Phlebotomy
Other Intervention Name(s)
Venesection
Intervention Description
Phlebotomy involves the removal of blood (approximately 500mL) each week until body iron levels reach the low-normal level
Primary Outcome Measure Information:
Title
Severity of liver disease
Time Frame
6 months after final treatment
Secondary Outcome Measure Information:
Title
Severity of metabolic disease
Time Frame
6 months after final treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 18y or older
Diagnosis of Non-alcoholic Fatty Liver Disease
Exclusion Criteria:
Unable or unwilling to provide informed consent
Alcohol consumption of >10g/day for women and >20g/day for men
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie D Beaton, MD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23441892
Citation
Beaton MD, Chakrabarti S, Levstik M, Speechley M, Marotta P, Adams P. Phase II clinical trial of phlebotomy for non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2013 Apr;37(7):720-9. doi: 10.1111/apt.12255. Epub 2013 Feb 26.
Results Reference
derived
Learn more about this trial
Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease
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