Glutamine Role in Preventing Vaso-occlusive Crisis Among SCD Patients

NCT05371184 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-01-09

No results posted yet for this study

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

Interventions

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

Standard of care

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Fatma SE Ebeid, MD · Ain Shams University, Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-04
Primary Completion
2023-01-03
Completion
2024-01-07

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05371184 on ClinicalTrials.gov