<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03250572</url>
  </required_header>
  <id_info>
    <org_study_id>9875</org_study_id>
    <nct_id>NCT03250572</nct_id>
  </id_info>
  <brief_title>Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among NAFLD Patients</brief_title>
  <official_title>Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among Non-alcoholic Fatty Liver Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to assess the relation between serum ferritin and hepatic fibrosis in&#xD;
      patients with NAFLD. It included 83 patients with NAFLD with or without hepatic fibrosis, in&#xD;
      addition to 30 healthy subjects included as controls. Measurement of serum ferritin and its&#xD;
      correlation with steatosis and fibrosis was done.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: many studies have found a relationship between hepatic iron, serum ferritin and&#xD;
      NAFLD or its progress. Aim of the work: is to assess the value of serum ferritin as a&#xD;
      non-invasive marker in prediction of hepatic fibrosis in NAFLD. Methods: This study included&#xD;
      113 subjects who were classified into 3 groups. Group I: included 30 healthy subjects as&#xD;
      control with no evidence of NAFLD by liver biopsy. Group II: included 31 NAFLD patients&#xD;
      without fibrosis proved by liver biopsy. Group III: included 52 patients with hepatic&#xD;
      fibrosis on top of NAFLD proved by liver biopsy. Serum ferritin was determined using Ferritin&#xD;
      ELISA kit. FIB4 was calculated and liver biopsy was done for all patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum ferritin in patients with hepatic fibrosis on top of NAFLD</measure>
    <time_frame>1 year</time_frame>
    <description>measurement of serum ferritin in patients with hepatic fibrosis on top NAFLD in comparison with normal control and simple steatosis</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">113</enrollment>
  <condition>Non-Alcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>NAFLD patients without hepatic fibrosis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>NAFLD patients with hepatic fibrosis</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum ferritin</intervention_name>
    <description>serum samples and ferritin ELISA test</description>
    <arm_group_label>NAFLD patients with hepatic fibrosis</arm_group_label>
    <arm_group_label>NAFLD patients without hepatic fibrosis</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Group I: included 30 healthy subjects as control. Group II: included 31 patients with NAFLD&#xD;
        without liver fibrosis. Group III: included 52 patients with hepatic fibrosis on top of&#xD;
        NAFLD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients with NAFLD with or without hepatic fibrosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant alcohol consumption, other causes of liver disease such as viral&#xD;
             hepatitis, schistosomiasis, autoimmune, hereditary, drug induced, or decompensated&#xD;
             liver cirrhosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 12, 2017</last_update_submitted>
  <last_update_submitted_qc>August 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Shereen Abou Bakr Saleh</investigator_full_name>
    <investigator_title>Asisstant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03250572
org study id: 9875
nct id: NCT03250572
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Control
time perspective: Prospective
measure: Serum ferritin in patients with hepatic fibrosis on top of NAFLD
time frame: 1 year
description: measurement of serum ferritin in patients with hepatic fibrosis on top NAFLD in comparison with normal control and simple steatosis
arm group label: control group
arm group label: NAFLD patients without hepatic fibrosis
arm group label: NAFLD patients with hepatic fibrosis
intervention type: Diagnostic Test
intervention name: serum ferritin
description: serum samples and ferritin ELISA test
arm group label: NAFLD patients with hepatic fibrosis
arm group label: NAFLD patients without hepatic fibrosis
arm group label: control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Shereen Abou Bakr Saleh
investigator title: Asisstant Professor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease