This is a study to determine the efficacy of L-glutamine as therapy for sickle cell anemia and sickle O-thalassemia.

Condition	Treatment or Intervention	Phase
Anemia, Sickle Cell Thalassemia	Drug: L-glutamine	Phase II Phase III

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 above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Diagnosis of sickle cell anemia or sickle beta O-thalassemia
• History of at least 3 episodes of painful crisis during the past 12 months
• PT INR no greater than 2.0
• Albumin at least 3.0 g/dL

Exclusion criteria:

• Any other significant medical condition, including diabetes mellitus (with untreated fasting blood sugar greater than 115), that required hospitalization within the past 2 months
• Received any blood products within the past 3 months
• History of stroke
• Received other antisickling agents within the past 12 months

California
      Harbor-UCLA Research and Education Institute, Torrance,  California,  90502,  United States; Recruiting

Study ID Numbers:  FD-R-2028-01; G002028;; FD-R-002028-01
Record last reviewed:  January 2002
Record first received:  January 24, 2002
ClinicalTrials.gov Identifier:  NCT00029887
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09