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

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among Non-alcoholic Fatty Liver Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250572
• Other study ID #: 9875
• Status: Completed
• Phase: N/A
• First received: August 8, 2017
• Last updated: August 12, 2017
• Start date: June 2015
• Est. completion date: November 2016

Study information

• Verified date: August 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: November 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• adult patients with NAFLD with or without hepatic fibrosis

Exclusion Criteria:

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• serum ferritin
serum samples and ferritin ELISA test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum ferritin in patients with hepatic fibrosis on top of NAFLD	measurement of serum ferritin in patients with hepatic fibrosis on top NAFLD in comparison with normal control and simple steatosis	1 year