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Iron Deficiency Anemia in Childern With Liver Cirrhosis (IDA)

Primary Purpose

Iron Deficiency, Anaemia in Children, Liver Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transferrin receptor concentration
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Iron Deficiency, Anaemia in Children

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • all childern with liver cirrhosis in GIT and hepatology unit

Exclusion Criteria:

  • Neonates less than one month
  • childern with other liver diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    transferrin receptor concentration

    Arm Description

    Prevelance of iron deficiency in this patients

    Outcomes

    Primary Outcome Measures

    Prevelance of IDA in liver cirrhosis
    To evaluate results

    Secondary Outcome Measures

    Full Information

    First Posted
    March 23, 2018
    Last Updated
    March 23, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03482076
    Brief Title
    Iron Deficiency Anemia in Childern With Liver Cirrhosis
    Acronym
    IDA
    Official Title
    Prevelance of Iron Deficiency Anemia in Liver Cirrhosis in Childern
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    June 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Iron deficiency anemia is a common complication of liver cirrhosis in childern and may affects there life this study to improve the outcome of these patients
    Detailed Description
    Patients with cirrhosis are at risk of developing both IDA and anemia of chronic disease concomitantly, and there adverse effects can deteriorate general condition and affect of quality of life in these patients .Also because it is easier to correct IDA than anemia of chronic disease, so this study of the prevalence of IDA helping us in the diagnosis and treatment of IDA and can reduce the need for other diagnostic tests and improve the quality of life in patients with cirrhosis .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency, Anaemia in Children, Liver Cirrhosis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    transferrin receptor concentration
    Arm Type
    Other
    Arm Description
    Prevelance of iron deficiency in this patients
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    transferrin receptor concentration
    Intervention Description
    Sandwich radio-imunoassay
    Primary Outcome Measure Information:
    Title
    Prevelance of IDA in liver cirrhosis
    Description
    To evaluate results
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: all childern with liver cirrhosis in GIT and hepatology unit Exclusion Criteria: Neonates less than one month childern with other liver diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bahaa Khaled Mohamed
    Phone
    +201002755105
    Ext
    002
    Email
    drbahaakhaled@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nagla Hassan Ibrahim

    12. IPD Sharing Statement

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    Iron Deficiency Anemia in Childern With Liver Cirrhosis

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