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

Primary Purpose

Sickle Cell Disease

Status

Recruiting

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

L-Glutamine, Oral Powder for Reconstitution

Standard of care

About this trial

This is an interventional prevention trial for Sickle Cell Disease focused on measuring glutamine, vasooclussive crisis, sickle cell disease, Egypt

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Faculty of Medicine Ain Shams University Research Institute- Clinical Research CenterRecruiting
Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cases

control

Arm 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

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

Outcomes

Primary Outcome Measures

Number of pain crises

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

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

Full Information

NCT ID

NCT05371184

First Posted

May 4, 2022

Last Updated

May 7, 2022

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT05371184

Brief Title

Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients

Acronym

Glu_SCD_Egy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 4, 2022 (Actual)

Primary Completion Date

July 4, 2023 (Anticipated)

Study Completion Date

August 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

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.

Data Monitoring Committee

Yes

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Disease

Keywords

glutamine, vasooclussive crisis, sickle cell disease, Egypt

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cases

Arm Type

Experimental

Arm 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

Arm Title

control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

L-Glutamine, Oral Powder for Reconstitution

Other Intervention Name(s)

L-Glutamine Powder

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard of care

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of pain crises

Description

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

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Changes in transcranial doppler

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fatma SE Ebeid, MD

Phone

+201095569596

dr.fatma_ebeid@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fatma SE Ebeid, MD

Organizational Affiliation

Ain Shams University, Faculty of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Cairo

State/Province

Non-US

ZIP/Postal Code

11566

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fatma Soliman E Ebeid

Phone

01095569596

dr.fatma_ebeid@yahoo.com

Facility Name

Ain Shams University

City

Cairo

ZIP/Postal Code

11566

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fatma Ebeid, MD

Phone

01095569596

dr.fatma_ebeid@yahoo.com

First Name & Middle Initial & Last Name & Degree

Nhal Hussien, MD

Phone

01001053961

nihal.hussien.ali@gmail.co,

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients

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