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L-glutamine Therapy for Sickle Cell Anemia



L-glutamine Therapy for Sickle Cell Anemia

For Condition: Thalassemia,Anemia, Sickle Cell
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: This is a study to determine the efficacy of L-glutamine as therapy for sickle cell anemia and sickle O-thalassemia.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Minimum Age/Maximum Age: 5 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 80

Location and Contact Information:

Harbor-UCLA Research and Education Institute *Recruiting*
Torrance,  California,  90502
United States
Recruiting Yutaka  Niihara 310-222-3695


Additional Information:
Study ID Numbers:
  FD-R-2028-01;  FD-R-002028-01,G002028;
Study Start Date: September 2001
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029887

Other Anemia, Sickle Cell Studies:
1. Stem Cell Transplantation after Reduced-Dose Chemotherapy for Patients with Sickle Cell Disease or Thalassemia

2. Prevention of Cerebral Infarction in Sickle Cell Anemia - Comprehensive Sickle Cell Center

3. Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients

4. Indices of Severity and Prognosis for Sickle Cell Disease

5. L-glutamine Therapy for Sickle Cell Anemia

Related Studies:

Other Anemia, Sickle Cell Clinical Trials
Other California Clinical Trials
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L-glutamine Therapy for Sickle Cell Anemia

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