Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients

• ClinicalTrials.gov Identifier: NCT03903133
• Recruitment Status: Unknown
• First Posted: April 4, 2019
• Last Update Posted: April 16, 2020
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Fatma Soliman Elsayed Ebeid, Ain Shams University

Tracking Information

• First Submitted Date: September 6, 2016
• First Posted Date: April 4, 2019
• Last Update Posted Date: April 16, 2020
• Actual Study Start Date: June 1, 2016
• Estimated Primary Completion Date: June 1, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 3, 2019): Oxidative stress markers [ Time Frame: Two years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: April 3, 2019): Endothelial monocyte-activating polypeptide II [ Time Frame: Two year ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Sickle Cell Disease

Intervention

Drug: 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)

Other Name: Antioxidant

Study Arms

vitamin E supplementation

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: Drug: Vitamin E

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 3, 2019): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 1, 2021
• Estimated Primary Completion Date: June 1, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03903133
• Other Study ID Numbers: AinS HOnc 01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Fatma Soliman Elsayed Ebeid, Ain Shams University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ain Shams University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Fatma SE Ebeid, MD; Ain Shams University, Faculty of Medicine

• PRS Account: Ain Shams University
• Verification Date: April 2020