Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients

NCT05371184 | Completed Phase 4 DMC

• 1 other identifier: FMASU MD 199/ 2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

Sickle Cell Disease

Keywords

glutamine, vasooclussive crisis, sickle cell disease, Egypt

Outcome Measures

Primary Outcomes (1)

• Number of pain crises

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

  24 weeks

Secondary Outcomes (1)

• Changes in transcranial doppler

  24 weeks

Study Arms (2)

cases

EXPERIMENTAL

• 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

control

ACTIVE COMPARATOR

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

Other: Standard of care

Interventions

L-Glutamine, Oral Powder for Reconstitution DRUG

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

Also known as: L-Glutamine Powder

cases

Standard of care OTHER

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

control

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with sickle cell trait and other hemoglobinopathy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (2)

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

Cairo, Non-US, 11566, Egypt

Location

Ain Shams University

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Glutamine; Powders; Standard of Care

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral; Dosage Forms; Pharmaceutical Preparations; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fatma SE Ebeid, MD

  Ain Shams University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of pediatric hematology ,oncology and bone marrow transpalnt

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 12, 2022
• Study Start: January 4, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 7, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)