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Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03903133
Enrollment
50
Registered
2019-04-04
Start date
2016-06-01
Completion date
2023-05-01
Last updated
2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

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.

Interventions

DRUGVitamin 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)

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Oxidative stress markersTwo years

Secondary

MeasureTime frame
Endothelial monocyte-activating polypeptide IITwo year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026