This is a study to determine the efficacy of L-glutamine as therapy for sickle cell anemia and sickle O-thalassemia.
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.
Condition | Anemia, Sickle Cell, Thalassemia |
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Treatment | L-glutamine |
Clinical Study Identifier | NCT00029887 |
Sponsor | FDA Office of Orphan Products Development |
Last Modified on | 7 November 2020 |
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