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

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.
 
ClinicalTrials.gov Identifier: NCT00641524
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
University of Western Ontario, Canada

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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Procedure: Phlebotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
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
Study Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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
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Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
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Principal Investigator: Melanie D Beaton, MD University of Western Ontario, Canada
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT00641524    
Other Study ID Numbers: beatonclf
First Posted: March 24, 2008    Key Record Dates
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:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases