CompletedNCT03903133Updated May 3, 2023

Endothelial Monocyte-activating Polypeptide-II in Egyptian Sickle Patients

A Phase 4 interventional study of Vitamin E in Sickle Cell Disease, sponsored by Ain Shams University. Completed. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Ain Shams University · Phase 4, Interventional, and Supportive care

From the registry’s dates

Registered 3 months after the study started (first participant enrolled Jun 2016, registered Sep 2016).

Phase: Phase 4
Study type: Interventional
Enrollment: 50
Allocation: Not applicable
Ages: 2 Years to 18 Years
Sex: All

Study 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 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 studied

Sickle Cell Disease

Browse trials for

Anemia, Sickle Cell 1,125

In context

Anemia, Sickle Cell

1,125 studies on the registry are indexed under Anemia, Sickle Cell; 239 are open to participants now.

This study's enrollment of 50 is above the median of 40 across 762 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Patients with any inflammatory condition within one month prior to enrollment.

Study design

Phase: Phase 4
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 50 participants (actual)

Study arms

Other
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)
Drug: Vitamin E

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)
Also known as: Antioxidant

What researchers measure

Primary outcomes

Oxidative stress markers
Time frame: Two years

Secondary outcomes

Endothelial monocyte-activating polypeptide II
Time frame: Two year

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2016 to primary completion in May 2023, 83 months.

Of 22 phase 4 interventional studies under Anemia, Sickle Cell, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 41. This study's 83 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 6, 2016
First posted: Apr 4, 2019
StartActual: Jun 1, 2016
Primary completionActual: May 1, 2023
CompletionActual: May 1, 2023
Last update: May 3, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03903133
Lead sponsor: Ain Shams University
Responsible party: Fatma Soliman Elsayed Ebeid, MD (Professor of Pediatrics, Ain Shams University) — Principal investigator
First posted: Apr 4, 2019
Start date: Jun 1, 2016
Primary completion: May 1, 2023
Completion: May 1, 2023
Last update: May 3, 2023

Study contacts

Fatma SE Ebeid, MD

principal investigator · Ain Shams University, Faculty of Medicine

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vitamin E

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