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Association Between Non-alcoholic Fatty Liver Disease and Iron Status (BAFLA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Ornit Cohen, Barzilai Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307254
First Posted: March 2, 2011
Last Update Posted: September 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Prof Doron Zamir
Information provided by (Responsible Party):
Ornit Cohen, Barzilai Medical Center
  Purpose

The investigators hypothesize that low iron storages protects from and down-grades non-alcoholic fatty liver disease.

The aim of the study is to show the association between the severity of Non-alcoholic fatty liver disease to low iron status.


Condition Intervention
NAFLD - Non Alcoholic Fatty Liver Disease Procedure: blood analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: (BAFLA- Barzilai Fatty Liver and Iron Metabolism Study)

Resource links provided by NLM:


Further study details as provided by Ornit Cohen, Barzilai Medical Center:

Primary Outcome Measures:
  • grade of fatty liver disease [ Time Frame: 1 year ]

Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non alcoholic fatty liver disease Procedure: blood analysis
A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)
control Procedure: blood analysis
A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)

Detailed Description:

Patients that will pass a CT scan that includes the abdomen will be asked to participate at our study. These patients will be divided into two groups - with and w/o fatty liver. The severity of fatty liver will be determined using the CT scan (as well as other parameters, such as the size of subcutaneous fat layer). Within 72 hours from the scan, a venous blood test will be taken from the enrolled patients (together with a BMI calculation and a blood pressure measurements). In the blood test we will examine liver functions, iron status etc.

This is a preliminary study that will aid in planning future strategies to treat or even prevent fatty liver (one of the epidemics of our century).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients that will pass a CT scan at our institution. The scan must include the abdomen, with or without any contrast material.
Criteria

Inclusion Criteria:

  • age>18
  • BMI>25

Exclusion Criteria:

  • pregnancy
  • unable to sign an informed consent (legally)
  • known solid/hematological malignancy
  • hemoglobinopathy or myelodysplastic disease (not including G6PD deficiency)
  • active or carrier of viral hepatitis
  • treated a drug the cause fatty liver (eg. amiodarone, tetracyclin, HAART, steroid treatment > 3 months)
  • consumption of > 120g ethanol per week
  • primary liver disease (eg. glycogen storage disease)
  • CRP>20
  • acute intoxication
  • surgery in previous 7 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307254


Contacts
Contact: Albert Grinshpun 972-54-5615563 albert.grinshpun@mail.huji.ac.il

Locations
Israel
Barzilai medical center Recruiting
Ashkelon, Israel, 78278
Contact: Albert Grinshpun    972-54-5615563    albert.grinshpun@mail.huji.ac.il   
Principal Investigator: Zamir Doron, Prof         
Sponsors and Collaborators
Ornit Cohen
Prof Doron Zamir
  More Information

Responsible Party: Ornit Cohen, r&d unit, Barzilai Medical Center
ClinicalTrials.gov Identifier: NCT01307254     History of Changes
Other Study ID Numbers: BAFLA
First Submitted: January 5, 2011
First Posted: March 2, 2011
Last Update Posted: September 20, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases