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Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Vitamin E
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sickle Cell Disease

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with sickle cell disease as confirmed by qualitative and quantitative analysis of hemoglobin using high performance liquid chromatography (HPLC) at their steady state.

Exclusion Criteria:

  • Patients with any inflammatory condition within one month prior to enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    vitamin E supplementation

    Arm Description

    vitamin E supplementation for three months (400-600 mg/day) (400 mg/day in those weighed less than 20 kg and 600 mg/day in those weighed at least 20 kg)

    Outcomes

    Primary Outcome Measures

    Oxidative stress markers

    Secondary Outcome Measures

    Endothelial monocyte-activating polypeptide II

    Full Information

    First Posted
    September 6, 2016
    Last Updated
    May 2, 2023
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03903133
    Brief Title
    Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients
    Official Title
    Endothelial Monocyte-activating Polypeptide-II as an Endothelial Dysfunction Marker and Its Relation to the Oxidative Stress in Egyptian Sickle Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    May 1, 2023 (Actual)
    Study Completion Date
    May 1, 2023 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study objectives to assess the role of endothelial monocyte-activating polypeptide II (EMAP II) as a marker of endothelial dysfunction and disturbed angiogenesis in sickle cell disease and to identify its correlation With the oxidative status.
    Detailed Description
    Study design: Screening/Baselie Phase Detailed medical history with special emphasis on demographic data, transfusion and chelation therapy, disease modifying therapy Thorough clinical examination Laboratory investigations to be done will include: Liver function test Marker of hemolysis Serum ferritin . Complete blood count(CBC) Hemoglobin electrophoresis Determination of serum levels of EMAP II Lipid Peroxidation (Malondialdehyde Concentration.), Superoxide Dismutase activity, Catalase activity, Glutathione Peroxidase activity, Glutathione Reductase activity, Vitamin E concentration, GSH The patients under investigations will receive vitamin E supplementation for three months Patients will be followed up for clinical assessment lying stress on frequency and severity of sickling crisis, length of hospital admission, and frequency and severity of painful crisis The biochemical investigations, EMAPII and oxidative stress biomarkers will be measured also after the three months vitamin E oral administration. Statistical analysis Result will be expressed as the mean (+/-) standard deviation (SD). For all tests significance was set at P<0.05. All statistical analysis will be performed using software package SPSS version 17.0 (SPSS Inc,Chicago, IL, USA). Differences over time will be tested with analysis covariance (ANOVA) repeated measures. Repeated measures analysis will be used to test treatment and time effects in addition to group -by- time interaction for clinical laboratory parameters. In cases where interactions will be identified, post hoc comparisons will be adjusted using Bonferroni correlations.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sickle Cell Disease

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    vitamin E supplementation
    Arm Type
    Other
    Arm Description
    vitamin E supplementation for three months (400-600 mg/day) (400 mg/day in those weighed less than 20 kg and 600 mg/day in those weighed at least 20 kg)
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin E
    Other Intervention Name(s)
    Antioxidant
    Intervention Description
    vitamin E supplementation for three months (400-600 mg/day) (400 mg/day in those weighed less than 20 kg and 600 mg/day in those weighed at least 20 kg)
    Primary Outcome Measure Information:
    Title
    Oxidative stress markers
    Time Frame
    Two years
    Secondary Outcome Measure Information:
    Title
    Endothelial monocyte-activating polypeptide II
    Time Frame
    Two year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with sickle cell disease as confirmed by qualitative and quantitative analysis of hemoglobin using high performance liquid chromatography (HPLC) at their steady state. Exclusion Criteria: Patients with any inflammatory condition within one month prior to enrollment.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fatma SE Ebeid, MD
    Organizational Affiliation
    Ain Shams University, Faculty of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients

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