Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients

Sickle Cell Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

• NCT number: NCT03903133
• Study type: Interventional
• Source: Ain Shams University
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2016
• Completion date: May 1, 2023