L-Glutamine Therapy for Sickle Cell Anemia

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    FDA Office of Orphan Products Development
Updated on 7 November 2020
anemia
glutamine
thalassemia

Summary

This is a study to determine the efficacy of L-glutamine as therapy for sickle cell anemia and sickle O-thalassemia.

Description

Sickle cell anemia is one of the most common and devastating hereditary disorders with significant morbidity and mortality affecting individuals of African-American heritage. No safe effective therapy is yet available. An ideal agent would be one that is readily available, effective, and safe even with chronic use. Early studies using L-glutamine in a few patients show promising results. This is an amino acid that has been used widely for other purposes and shown to be safe. Patients are assigned randomly to receive L-glutamine or placebo orally 3 times a day for 24 weeks after which patients will cross over to the other treatment arm for 24 weeks. Clinical parameters, adverse effects attributable to L-glutamine, and physiological parameters will be monitored throughout the study.

Details
Condition Anemia, Sickle Cell, Thalassemia
Treatment L-glutamine
Clinical Study IdentifierNCT00029887
SponsorFDA Office of Orphan Products Development
Last Modified on7 November 2020

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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