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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903133
• Other study ID #: AinS HOnc 01
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2016
• Est. completion date: May 1, 2023

Study information

• Verified date: May 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative stress markers		Two years
Secondary	Endothelial monocyte-activating polypeptide II		Two year