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Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00641524
First Posted: March 24, 2008
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Western Ontario, Canada
  Purpose
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.

Condition Intervention
Non-alcoholic Fatty Liver Disease Procedure: Phlebotomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • Severity of liver disease [ Time Frame: 6 months after final treatment ]

Secondary Outcome Measures:
  • Severity of metabolic disease [ Time Frame: 6 months after final treatment ]

Enrollment: 45
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
treatment
Iron depletion via phlebotomy
Procedure: Phlebotomy
Phlebotomy involves the removal of blood (approximately 500mL) each week until body iron levels reach the low-normal level
Other Name: Venesection

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641524


Locations
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Principal Investigator: Melanie D Beaton, MD University of Western Ontario, Canada
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT00641524     History of Changes
Other Study ID Numbers: beatonclf
First Submitted: March 17, 2008
First Posted: March 24, 2008
Last Update Posted: May 13, 2016
Last Verified: May 2016

Keywords provided by University of Western Ontario, Canada:
Non-alcoholic fatty liver disease
liver fibrosis
metabolic syndrome
iron overload
phlebotomy

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases