Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Sickle Cell Disease

Treatments: Drug: Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT03903133

AinS HOnc 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

vitamin E supplementation

Other group

Description:

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)

Treatment:

Drug: Vitamin E