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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT00641524
First received: March 17, 2008
Last updated: May 12, 2016
Last verified: May 2016
  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: 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:


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 ]

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: March 17, 2008
Last Updated: May 12, 2016
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:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases

ClinicalTrials.gov processed this record on August 25, 2016