Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients

May 2, 2023 updated by: Fatma Soliman Elsayed Ebeid, MD, Ain Shams University

Endothelial Monocyte-activating Polypeptide-II as an Endothelial Dysfunction Marker and Its Relation to the Oxidative Stress in Egyptian Sickle Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: vitamin E supplementation
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)
Drug: Vitamin E
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)
Other Names:
  • Antioxidant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oxidative stress markers
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Endothelial monocyte-activating polypeptide II
Time Frame: Two year
Two year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AinS HOnc 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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