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

This study is currently recruiting participants.
Verified August 2011 by University of Western Ontario, Canada
Sponsor:
Information provided by:
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT00641524
First received: March 17, 2008
Last updated: August 15, 2011
Last verified: August 2011
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Phlebotomy as a Treatment for Non-alcoholic Fatty Liver Disease

Resource links provided by NLM:

MedlinePlus related topics: Iron Liver Diseases
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of metabolic disease [ Time Frame: 6 months after final treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641524

Contacts
Contact: Melanie D Beaton, MD 519-663-3344 Melanie.Beaton@lhsc.on.ca
Contact: Paul C Adams, MD 519-663-5375 padams@uwo.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Melanie D Beaton, MD     519-663-3344     melanie.beaton@lhsc.on.ca    
Contact: cathy wild     519-663-3344     cathy.wild@lhsc.on.ca    
Principal Investigator: Melanie D Beaton, MD            
Sub-Investigator: Paul C Adams, MD            
Sub-Investigator: Paul Marotta, MD            
Sub-Investigator: Mark Levstik, MD            
Sponsors and Collaborators
University of Western Ontario, Canada
Investigators
Principal Investigator: Melanie D Beaton, MD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Dr. Melanie D Beaton, MD, FRCPC Assisstant Professor, Department of Medicine, University of Western Ontario
ClinicalTrials.gov Identifier: NCT00641524     History of Changes
Other Study ID Numbers: beatonclf
Study First Received: March 17, 2008
Last Updated: August 15, 2011
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013