Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients

Phase 4

Completed

• Conditions: Sickle Cell Disease
• Interventions: Drug: Vitamin E

• Registration Number: NCT03903133
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-04
• Status Verified: 2023-05
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vitamin E supplementation	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)

Primary Outcome Measures

Name	Time	Method
Oxidative stress markers	Two years

Secondary Outcome Measures

Name	Time	Method
Endothelial monocyte-activating polypeptide II	Two year