The primary purpose is to evaluate the effect of L-glutamine therapy on exercise endurance and breath by breath exercise response of sickle cell anemia patients The secondary purpose is to assess the effect of L-glutamine on incidence of painful crises; level of chronic pain, and amount of daily requirement for narcotics.
This is a phase II, prospective, randomized, double-blind, placebo-controlled, parallel-group,study to evaluate the safety and efficacy of oral L-glutamine therapy for patients with sickle cell anemia or sickle β°-thalassemia who are at least 18 years old with focus on the aspect of exercise endurance. In this study, the patients will orally take L-glutamine or placebo twice daily, and clinical and hematological parameters will be monitored. The adverse events,especially those attributable to L-glutamine therapy, will also be monitored. The data obtained will be essential in understanding the role of L-glutamine in therapy for sickle cell anemia and sickle β°-thalassemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (\>66.7 kg)
Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine
LA Biomed at Harbor-UCLA Medical Center
Torrance, California, United States
Effect of L-glutamine Therapy on Exercise Endurance of Sickle Cell Anemia Patients
Exercise endurance will be examined at each visit. Change from baseline will be reported at weeks 8 and 12
Time frame: Baseline, Weeks 8 and 12
Effect of L-glutamine Therapy on Breath by Breath Exercise of Sickle Cell Patients
Breath by breath exercise will be examined at each visit. Change from baseline will be reported at weeks 8 and 12
Time frame: Baseline, Weeks 18 and 12
Effect of Oral L-glutamine on Incidence of Painful Crises
Incidence of panful crises will be assessed at each visit.
Time frame: From Week 0 through Week 12
Effect of Oral L-glutamine on Amount of Daily Requirement for Narcotics
Amount of daily requirement for narcotics will assessed at each visit.
Time frame: From Week 0 through Week 20
Effect of Oral L-glutamine on Level of Chronic Pain
Level of chronic pain will be assessed at each visit.
Time frame: From Week 0 to Week 12
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