Conditions: Sickle Cell Anemia Thalassemia
Keywords: sickle cell disease sickle cell anemia L-glutamine Sickle Cell Anemia (homozygous) Sickle β°-Thalassemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: L-glutamine group will be given at the following dosage:

17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily \>66.7 at 15 g 2X daily arm 2: Maltodextrin group will be given at the following dosage:

17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily \>66.7 at 15 g 2X daily

Interventions: intervention 1: L-Glutamine intervention 2: Placebo
Intervention descriptions: intervention 1: 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) intervention 2: Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine

Protocol document: