Association Between Non-alcoholic Fatty Liver Disease and Iron Status

NAFLD - Non Alcoholic Fatty Liver Disease Clinical Trial

— BAFLA  

Official title:

(BAFLA- Barzilai Fatty Liver and Iron Metabolism Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01307254
• Other study ID #: BAFLA
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2011
• Last updated: September 19, 2012
• Start date: January 2011
• Est. completion date: July 2013

Study information

• Verified date: September 2012
• Source: Barzilai Medical Center
• Contact: Albert Grinshpun
• Phone: 972-54-5615563
• Email: albert.grinshpun[@]mail.huji.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD - Non Alcoholic Fatty Liver Disease

Intervention

Procedure:
• blood analysis
A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)

Locations

Country	Name	City	State
Israel	Barzilai medical center	Ashkelon

Sponsors (2)

Lead Sponsor	Collaborator
Ornit Cohen	Prof Doron Zamir

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	grade of fatty liver disease		1 year	No