Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Vitamin E
Sponsored by
About this trial
This is an interventional supportive care trial for Sickle Cell Disease
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
vitamin E supplementation
Arm 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)
Outcomes
Primary Outcome Measures
Oxidative stress markers
Secondary Outcome Measures
Endothelial monocyte-activating polypeptide II
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03903133
Brief Title
Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients
Official Title
Endothelial Monocyte-activating Polypeptide-II as an Endothelial Dysfunction Marker and Its Relation to the Oxidative Stress in Egyptian Sickle Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitamin E supplementation
Arm Type
Other
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Other Intervention Name(s)
Antioxidant
Intervention 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)
Primary Outcome Measure Information:
Title
Oxidative stress markers
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Endothelial monocyte-activating polypeptide II
Time Frame
Two year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma SE Ebeid, MD
Organizational Affiliation
Ain Shams University, Faculty of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients
We'll reach out to this number within 24 hrs