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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2016

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

6.9 years

First QC Date

September 6, 2016

Last Update Submit

May 2, 2023

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

  • Oxidative stress markers

    Two years

Secondary Outcomes (1)

  • Endothelial monocyte-activating polypeptide II

    Two year

Study Arms (1)

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)

Drug: Vitamin E

Interventions

Vitamin EDRUG

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
vitamin E supplementation

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with sickle cell disease as confirmed by qualitative and quantitative analysis of hemoglobin using high performance liquid chromatography (HPLC) at their steady state.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Vitamin EAntioxidants

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBiological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of Chemicals

Study Officials

  • Fatma SE Ebeid, MD

    Ain Shams University, Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

September 6, 2016

First Posted

April 4, 2019

Study Start

June 1, 2016

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

May 3, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share