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Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903133
Recruitment Status : Completed
First Posted : April 4, 2019
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Fatma Soliman Elsayed Ebeid, MD, Ain Shams University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Vitamin E Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Endothelial Monocyte-activating Polypeptide-II as an Endothelial Dysfunction Marker and Its Relation to the Oxidative Stress in Egyptian Sickle Patients
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : May 1, 2023
Actual Study Completion Date : May 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
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Arm Intervention/treatment
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 Name: Antioxidant


Outcome Measures
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Primary Outcome Measures :
  1. Oxidative stress markers [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Endothelial monocyte-activating polypeptide II [ Time Frame: Two year ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903133


Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Fatma SE Ebeid, MD Ain Shams University, Faculty of Medicine
More Information
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Responsible Party: Fatma Soliman Elsayed Ebeid, MD, Professor of Pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT03903133    
Other Study ID Numbers: AinS HOnc 01
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
 Vitamin E
Antioxidants
Vitamins
Micronutrients
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents