NCT00641524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

2.9 years

First QC Date

March 17, 2008

Last Update Submit

May 12, 2016

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic fatty liver diseaseliver fibrosismetabolic syndromeiron overloadphlebotomy

Outcome Measures

Primary Outcomes (1)

  • Severity of liver disease

    6 months after final treatment

Secondary Outcomes (1)

  • Severity of metabolic disease

    6 months after final treatment

Study Arms (1)

treatment

OTHER

Iron depletion via phlebotomy

Procedure: Phlebotomy

Interventions

PhlebotomyPROCEDURE

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

Also known as: Venesection
treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18y or older
  • Diagnosis of Non-alcoholic Fatty Liver Disease

You may not qualify if:

  • Unable or unwilling to provide informed consent
  • Alcohol consumption of \>10g/day for women and \>20g/day for men

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 23441892DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseLiver CirrhosisMetabolic SyndromeIron Overload

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesIron Metabolism Disorders

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Melanie D Beaton, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

CA(1)