Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients (Glu_SCD_Egy)

  • STATUS
    Recruiting
  • End date
    Aug 4, 2023
  • participants needed
    30
  • sponsor
    Ain Shams University
Updated on 27 June 2022
hydroxyurea
glutamine
blood transfusion
electrophoresis
vaso-occlusive crisis

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 adolescents' patients

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 poor outcomes in the short term and decreased quality of life in patients over the long term.

Although that L-glutamine has been recently approved by the FDA for the prevention of acute complications in sickle cell disease. However, there are many gaps in our understanding of its therapeutic implications in SCD. This study will assess the safety and efficacy of glutamine in preventing vaso-occlusive crisis (VOC) episodes in sickle cell pediatrics and adolescents' patients

Details
Condition Sickle Cell Disease
Treatment Standard of Care, L-Glutamine, Oral Powder for Reconstitution
Clinical Study IdentifierNCT05371184
SponsorAin Shams University
Last Modified on27 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

Patients with sickle cell trait and other hemoglobinopathy
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