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

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. Identifier: NCT01307254
Recruitment Status : Unknown
Verified September 2012 by Ornit Cohen, Barzilai Medical Center.
Recruitment status was:  Recruiting
First Posted : March 2, 2011
Last Update Posted : September 20, 2012
Prof Doron Zamir
Information provided by (Responsible Party):
Ornit Cohen, Barzilai Medical Center

Brief Summary:

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 or disease Intervention/treatment
NAFLD - Non Alcoholic Fatty Liver Disease Procedure: blood analysis

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).

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: (BAFLA- Barzilai Fatty Liver and Iron Metabolism Study)
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : July 2013

Group/Cohort Intervention/treatment
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)

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

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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 identifier (NCT number): NCT01307254

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Contact: Albert Grinshpun 972-54-5615563

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Barzilai medical center Recruiting
Ashkelon, Israel, 78278
Contact: Albert Grinshpun    972-54-5615563   
Principal Investigator: Zamir Doron, Prof         
Sponsors and Collaborators
Ornit Cohen
Prof Doron Zamir
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Responsible Party: Ornit Cohen, r&d unit, Barzilai Medical Center Identifier: NCT01307254    
Other Study ID Numbers: BAFLA
First Posted: March 2, 2011    Key Record Dates
Last Update Posted: September 20, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases