Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients

Phase 4

Completed

• Conditions: Sickle Cell Disease
• Interventions: Other: Standard of care; Drug: L-Glutamine, Oral Powder for Reconstitution

• Registration Number: NCT05371184
• Lead Sponsor: Ain Shams University

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 adolescents' patients

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 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

Study Timeline

• Study Start: 2022-01-04
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-07
• Study First Posted: 2022-05-12
• Primary Completion: 2023-01-03
• Status Verified: 2024-01
• Study Completion: 2024-01-07
• Last Update Submitted: 2024-01-07
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

Patients with sickle cell trait and other hemoglobinopathy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Standard of care	30 patients will be assigned as a control group to receive standard of care therapy without glutamine intake.
cases	L-Glutamine, Oral Powder for Reconstitution	• 30 patients will receive glutamine in a dose of 0.3 gm /kg/dose twice daily orally (up to a maximum of 15 g/dose) for 24 weeks as an add on to the SOC

Primary Outcome Measures

Name	Time	Method
Number of pain crises	24 weeks	The number of pain crises will be counted from day 1 till end of treatment at week 24

Secondary Outcome Measures

Name	Time	Method
Changes in transcranial doppler	24 weeks	Calculate the change in transcranial doppler (TCD) time-averaged mean of the maximum velocity (TAMMV) arterial cerebral blood flow through the measuring of TCD flow velocity at day1 and at Week 24

Trial Locations

Locations (2)

Ain Shams University; 🇪🇬 Cairo, Egypt

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center; 🇪🇬 Cairo, Non-US, Egypt