Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among NAFLD Patients

Completed

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Diagnostic Test: serum ferritin

• Registration Number: NCT03250572
• Lead Sponsor: Ain Shams University

Brief Summary

This study was designed to assess the relation between serum ferritin and hepatic fibrosis in patients with NAFLD. It included 83 patients with NAFLD with or without hepatic fibrosis, in addition to 30 healthy subjects included as controls. Measurement of serum ferritin and its correlation with steatosis and fibrosis was done.

Detailed Description

Background: many studies have found a relationship between hepatic iron, serum ferritin and NAFLD or its progress. Aim of the work: is to assess the value of serum ferritin as a non-invasive marker in prediction of hepatic fibrosis in NAFLD. Methods: This study included 113 subjects who were classified into 3 groups. Group I: included 30 healthy subjects as control with no evidence of NAFLD by liver biopsy. Group II: included 31 NAFLD patients without fibrosis proved by liver biopsy. Group III: included 52 patients with hepatic fibrosis on top of NAFLD proved by liver biopsy. Serum ferritin was determined using Ferritin ELISA kit. FIB4 was calculated and liver biopsy was done for all patients.

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-07
• Study Completion: 2016-11
• Status Verified: 2017-08
• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-08-12
• Last Update Submitted: 2017-08-12
• Study First Posted: 2017-08-15
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

• adult patients with NAFLD with or without hepatic fibrosis

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Exclusion Criteria

• Significant alcohol consumption, other causes of liver disease such as viral hepatitis, schistosomiasis, autoimmune, hereditary, drug induced, or decompensated liver cirrhosis.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NAFLD patients with hepatic fibrosis	serum ferritin	-
control group	serum ferritin	-
NAFLD patients without hepatic fibrosis	serum ferritin	-

Primary Outcome Measures

Name	Time	Method
Serum ferritin in patients with hepatic fibrosis on top of NAFLD	1 year	measurement of serum ferritin in patients with hepatic fibrosis on top NAFLD in comparison with normal control and simple steatosis