L-Glutamine Therapy for Sickle Cell Anemia - Tabular View

Tracking Information
First Received Date ^ICMJE	January 24, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	September 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00029887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	L-Glutamine Therapy for Sickle Cell Anemia
Official Title ^ICMJE	L-Glutamine Therapy for Sickle Cell Anemia
Brief Summary	This is a study to determine the efficacy of L-glutamine as therapy for sickle cell anemia and sickle O-thalassemia.
Detailed Description	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.
Study Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Condition ^ICMJE	Anemia, Sickle Cell Thalassemia
Intervention ^ICMJE	Drug: L-glutamine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Enrollment ^ICMJE	80
Completion Date	September 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	5 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00029887
Responsible Party
Study ID Numbers ^ICMJE	FD-R-2028-01, G002028;, FD-R-002028-01
Study Sponsor ^ICMJE	FDA Office of Orphan Products Development
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	FDA Office of Orphan Products Development
Verification Date	January 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP