Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients

Ain Shams University60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Sickle Cell Disease

Interventions

L-Glutamine, Oral Powder for ReconstitutionDRUG

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 careOTHER

Hydroxyurea 15-25 mg per kg per day and/ or blood transfusion therapy

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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. \-

Locations (2)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, Egypt

Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

Number of pain crises

The number of pain crises will be counted from day 1 till end of treatment at week 24

Time frame: 24 weeks

Secondary Outcomes

Changes in transcranial doppler

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

Time frame: 24 weeks

Data from ClinicalTrials.gov

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