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Completed

NCT Number: NCT00641524

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Fibrosis Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Iron Metabolism Disorders Iron Overload Liver Cirrhosis Liver Diseases Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phlebotomy

Procedure

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

Other names: Venesection

Primary outcomes

  1. Severity of liver disease

    Time frame: 6 months after final treatment

Secondary outcomes

  1. Severity of metabolic disease

    Time frame: 6 months after final treatment

Sponsors and collaborators

Lead sponsor

University of Western Ontario, Canada

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 24, 2008
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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