Status:
COMPLETED
Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients
Lead Sponsor:
Ain Shams University
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
Brief Summary
Prospective phase IV interventional open label randomized controlled trial to assess safety and efficacy of glutamine in preventing vaso-occlusive crisis (VOC) episodes in sickle cell pediatrics and a...
Detailed Description
Vaso-occlusive crisis (VOC) episodes are considered to be the cause of 95% of hospitalizations for sickle cell disease (SCD) patients. Prior studies have described pain management in SCD patients with...
Eligibility Criteria
Inclusion
- Children and adolescents diagnosed with sickle cell disease by haemoglobin electrophoresis and had at least two pain crises (no upper limit) documented during the previous year; a pain crisis is defined as pain leading to treatment with a parenteral administered narcotic or ketolac in an emergency department (ED) (or outpatient treatment centre) or during hospitalization.
- Patients receiving hydroxyurea at a fixed dose for at least 3 months before screening.
Exclusion
- Patients with sickle cell trait and other hemoglobinopathy.
- \-
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05371184
Start Date
January 4 2022
End Date
January 7 2024
Last Update
January 9 2024
Active Locations (2)
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1
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, Egypt, 11566
2
Ain Shams University
Cairo, Egypt, 11566