Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT03903133
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:
NCT03903133
Study Brief:
Protocol Section:
NCT03903133