- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05371184
Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients (Glu_SCD_Egy)
Safety and Efficacy of Glutamine in Preventing Vaso-occlusive Crisis Among Sickle Cell Disease Patients: Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Cairo, Egypt, 11566
- Ain Shams University
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Non-US
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Cairo, Non-US, Egypt, 11566
- Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: cases
• 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
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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
Other Names:
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Active Comparator: control
30 patients will be assigned as a control group to receive standard of care therapy without glutamine intake.
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Hydroxyurea 15-25 mg per kg per day and/ or blood transfusion therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of pain crises
Time Frame: 24 weeks
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The number of pain crises will be counted from day 1 till end of treatment at week 24
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in transcranial doppler
Time Frame: 24 weeks
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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
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24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatma SE Ebeid, MD, Ain Shams University, Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MD 199/ 2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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