L-Glutamine Therapy for Sickle Cell Anemia
L-Glutamine Therapy for Sickle Cell Anemia
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.
Inclusion Criteria:

 To be eligible to participate in the study, a patient must meet all of the following
 inclusion criteria:

 -  Patient is at least 18 years of age.

 -  Patient has been diagnosed with sickle cell anemia or sickle ß0-thalassemia
 (documented by hemoglobin electrophoresis).

 -  Patient has had at least two episodes of painful crises within 12 months of the
 screening visit.

 -  If the patient has been treated with an anti-sickling agent within three months of the
 screening visit, the therapy must have been continuous for at least three months with
 the intent to continue for the next 14 months.

 -  Patient or the patient's legally authorized representative has given written informed
 consent.

 -  If the patient is a female of child-bearing potential, she agrees to practice a
 recognized form of birth control during the course of the study.

 -  Patient is able to perform exercise tolerance test

 Exclusion Criteria:

 If the patient meets any of the following criteria, the patient must not be enrolled:

 -  Patient has a significant medical condition that required hospitalization (other than
 sickle painful crisis) within two months of the screening visit.

 -  Patient has diabetes mellitus with untreated fasting blood sugar >115 mg/dL.

 -  Patient has prothrombin time International Normalized Ratio (INR) > 2.0.

 -  Patient has serum albumin < 3.0 g/dl.

 -  Patient has received any blood products within three weeks of the screening visit.

 -  Patient has a history of uncontrolled liver disease or renal insufficiency.

 -  Patient is pregnant or lactating.

 -  Patient has been treated with an experimental anti-sickling medication/treatment
 (except hydroxyurea) within 30 days of the screening visit.

 -  Patient has been treated with an experimental drug within 30 days of the screening
 visit.

 -  There are factors that would, in the judgment of the investigator, make it difficult
 for the patient to comply with the requirements of the study.