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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Sickle Cell Disease

Treatments: Drug: L-Glutamine, Oral Powder for Reconstitution; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT05371184

FMASU MD 199/ 2021

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

cases

Experimental group

Description:

• 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

Treatment:

Drug: L-Glutamine, Oral Powder for Reconstitution

control

Active Comparator group

Description:

30 patients will be assigned as a control group to receive standard of care therapy without glutamine intake.

Treatment:

Other: Standard of care