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

NCT ID: NCT00641524

Last Updated: 2016-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment

Iron depletion via phlebotomy

Group Type OTHER

Phlebotomy

Intervention Type PROCEDURE

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

Interventions

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Phlebotomy

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

Intervention Type PROCEDURE

Other Intervention Names

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Venesection

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Western Ontario, Canada

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melanie D Beaton, MD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

References

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Beaton MD, Chakrabarti S, Levstik M, Speechley M, Marotta P, Adams P. Phase II clinical trial of phlebotomy for non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2013 Apr;37(7):720-9. doi: 10.1111/apt.12255. Epub 2013 Feb 26.

Reference Type DERIVED
PMID: 23441892 (View on PubMed)

Other Identifiers

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beatonclf

Identifier Type: -

Identifier Source: org_study_id

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