L-Glutamine Therapy for Sickle Cell Anemia and Sickle ß0 Thalassemia
Condition: Sickle Cell Anemia; Thalassemia
MeSH terms: Anemia; Thalassemia; Anemia, Sickle Cell
Intervention: L-glutamine; Placebo
Intervention description: Approximately 0.3 g/kg total daily dose of L-glutamine will be orally administered (over two doses), with a maximum total daily dose of 30 grams.; Approximately 0.3 g/kg total daily dose of maltodextrin placebo will be orally administered (over two doses), with a maximum total daily dose of 30 grams.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: sickle cell disease; sickle cell anemia; L-glutamine; Sickle Cell Anemia (homozygous); Sickle ß0-Thalassemia

Summary:

      The purpose of this research is to evaluate the effects of L-glutamine as a therapy for
      sickle cell anemia and sickle ß0-thalassemia. as evaluated by the number of occurrences of
      sickle cell crises.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible to participate in the study, a patient must meet all of the following
        inclusion criteria:

          -  Patient is at least five 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.

        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.