Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients

NCT05371184 — Phase 4, Completed, 60 participants, Ain Shams University

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Safety and Efficacy of Glutamine in Preventing Vaso-occlusive Crisis Among Sickle Cell Disease Patients: Randomized Controlled Study

Registry	NCT05371184, acronym Glu_SCD_Egy
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	60 (Actual)
Sponsor	Ain Shams University (Other)
Conditions	Sickle Cell Disease
Interventions	L-Glutamine, Oral Powder for Reconstitution, Standard of care (Drug, other)
Dates	start 2022-01-04, primary completion 2023-01-03, completion 2024-01-07, first posted 2022-05-12, last updated 2024-01-09
Locations	2 sites in Egypt

-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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
cases	Experimental	Drug: 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
control	Active comparator	Other: Standard of care	30 patients will be assigned as a control group to receive standard of care therapy without glutamine intake.

L-Glutamine, Oral Powder for Reconstitution (Drug), also known as L-Glutamine Powder: Glutamine is an essential amino acid. It will be provided in a powder form. It will be dissolved in at least 8 ounces of hot or cold liquid. It can also be mixed with a soft food such as pudding, applesauce, or yogurt. Then it will be Stirred and then eaten or drunken The Glutamine will be as an add on to the Standard of care
Standard of care (Other): Hydroxyurea 15-25 mg per kg per day and/ or blood transfusion therapy

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 2 Years to 18 Years

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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+Locations (2)

Facility	City	Country	Status
Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center	Cairo, Non-US	Egypt
Ain Shams University	Cairo	Egypt

+Investigators

Fatma SE Ebeid, MD, Principal investigator, Ain Shams University, Faculty of Medicine