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Sponsored by: |
FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00029887 |
This is a study to determine the efficacy of L-glutamine as therapy for sickle cell anemia and sickle O-thalassemia.
Condition | Intervention | Phase |
---|---|---|
Anemia, Sickle Cell Thalassemia |
Drug: L-glutamine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | L-Glutamine Therapy for Sickle Cell Anemia |
Estimated Enrollment: | 80 |
Study Start Date: | September 2001 |
Estimated Study Completion Date: | September 2004 |
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.
Ages Eligible for Study: | 5 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
United States, California | |
Harbor-UCLA Research and Education Institute | Recruiting |
Torrance, California, United States, 90502 | |
Contact: Yutaka Niihara, M.D. 310-222-3695 ysniihara@aol.com | |
Principal Investigator: Yutaka Niihara, M.D. |
Study ID Numbers: | FD-R-2028-01, G002028;, FD-R-002028-01 |
Study First Received: | January 24, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00029887 |
Health Authority: | United States: Food and Drug Administration |
Sickle O-thalassemia |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Anemia |
Anemia, Hemolytic Hemoglobinopathy Thalassemia Anemia, Sickle Cell Sickle cell anemia |