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

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05371184

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease	Drug: L-Glutamine, Oral Powder for Reconstitution Other: Standard of care	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 4, 2022

Anticipated Primary Completion Date :

Jul 4, 2023

Anticipated Study Completion Date :

Aug 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: L-Glutamine, Oral Powder for Reconstitution 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: L-Glutamine Powder
Active Comparator: control 30 patients will be assigned as a control group to receive standard of care therapy without glutamine intake.	Other: Standard of care Hydroxyurea 15-25 mg per kg per day and/ or blood transfusion therapy

Arm

Intervention/Treatment

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

Drug: L-Glutamine, Oral Powder for Reconstitution

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:

L-Glutamine Powder

Active Comparator: control

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

Other: Standard of care

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

Outcome Measures

Primary Outcome Measures

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

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 Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center	Cairo	Non-US	Egypt	11566
2	Ain Shams University	Cairo		Egypt	11566

Sponsors and Collaborators

Ain Shams University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatma Soliman Elsayed Ebeid, professor of pediatric hematology ,oncology and bone marrow transpalnt, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05371184

Other Study ID Numbers:

FMASU MD 199/ 2021

First Posted:

May 12, 2022

Last Update Posted:

May 12, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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.:

Keywords provided by Fatma Soliman Elsayed Ebeid, professor of pediatric hematology ,oncology and bone marrow transpalnt, Ain Shams University

glutamine, vasooclussive crisis, sickle cell disease, Egypt

Additional relevant MeSH terms:

Anemia, Sickle Cell

Study Results

No Results Posted as of May 12, 2022