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

This study is currently recruiting participants.

Verified by University of Western Ontario, Canada, January 2009

First Received: March 17, 2008 Last Updated: January 5, 2009 History of Changes

Sponsored by:	University of Western Ontario, Canada
Information provided by:	University of Western Ontario, Canada
ClinicalTrials.gov Identifier:	NCT00641524

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Evaluation of Phlebotomy as a Treatment for Non-Alcoholic Fatty Liver Disease

Resource links provided by NLM:

MedlinePlus related topics: 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:	36
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:

Phlebotomy involves the removal of blood (approximately 500mL) each week until body iron levels reach the low-normal level

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:	University of Western Ontario ( Dr. Melanie D Beaton, MD, FRCPC Assisstant Professor, Department of Medicine )
Study ID Numbers:	beatonclf
Study First Received:	March 17, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00641524 History of Changes
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

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic Steatohepatitis (NASH)
Digestive System Diseases
Hepatic Fibrosis

Fibrosis
Fatty Liver
Iron Overload
Iron

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on September 10, 2009