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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00641524
Enrollment
45
Registered
2008-03-24
Start date
2009-01-31
Completion date
2011-12-31
Last updated
2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic fatty liver disease, liver fibrosis, metabolic syndrome, iron overload, phlebotomy

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.

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.

Interventions

PROCEDUREPhlebotomy

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

Sponsors

University of Western Ontario, Canada
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Severity of liver disease6 months after final treatment

Secondary

MeasureTime frame
Severity of metabolic disease6 months after final treatment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026