Clinical trial NCT03903133: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sickle Cell Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Oxidative stress markers
timeFrame: Two years
Secondary outcomes:
measure: Endothelial monocyte-activating polypeptide II
timeFrame: Two year
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University, Faculty of Medicine
name: Fatma SE Ebeid, MD
role: PRINCIPAL_INVESTIGATOR
References: