Sickle Cell DiseasePhase 4NCT03903133
Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients
A Phase 4 study testing Vitamin E in people with Sickle Cell Disease, run by Ain Shams University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 1 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with sickle cell disease as confirmed by qualitative and quantitative analysis of hemoglobin using high performance liquid chromatography (HPLC) at their steady state.
Who cannot join
- Patients with any inflammatory condition within one month prior to enrollment.
About this study
Official title: Endothelial Monocyte-activating Polypeptide-II as an Endothelial Dysfunction Marker and Its Relation to the Oxidative Stress in Egyptian Sickle Patients
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Vitamin E
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
Also called Antioxidant
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)
| Study group | Role | What they receive |
|---|---|---|
| vitamin E supplementation | Other | 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) Receives: Drug: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress markers
Measured: Two years
Secondary outcomes (1)
Endothelial monocyte-activating polypeptide II
Measured: Two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Jun 2016
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Soliman Elsayed Ebeid, MD, Ain Shams University
- Investigators
- Fatma SE Ebeid, MD, Principal investigator, Ain Shams University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903133
- Sponsor's protocol ID
- AinS HOnc 01
- Status last verified
- May 2023
- First submitted
- 6 Sep 2016
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Monocyte-activating Polypeptide-II as an Endothelial Dysfunction Marker and Its Relation to the Oxidative Stress in Egyptian Sickle Patients
- ClinicalTrials.gov ID
- NCT03903133
- Acronym / sponsor ID
- AinS HOnc 01
- Conditions
- Sickle Cell Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vitamin E supplementation | Other | Drug: Vitamin Evitamin 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) |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with sickle cell disease as confirmed by qualitative and quantitative analysis of hemoglobin using high performance liquid chromatography (HPLC) at their steady state.
Key exclusion criteria (1 listed)
- Patients with any inflammatory condition within one month prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin EAlso: Antioxidantvitamin 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) | Drug | vitamin E supplementation |
Primary outcome
Oxidative stress markers
Time frame: Two years
1 secondary outcome
Endothelial monocyte-activating polypeptide II
Time frame: Two year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma SE Ebeid, MD principal investigator
Ain Shams University, Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin E in people with Sickle Cell Disease, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative stress markers (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.