|
L-glutamine Therapy for Sickle Cell Anemia Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about L-glutamine Therapy for Sickle Cell Anemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. L-glutamine Therapy for Sickle Cell Anemia Clinical research trials and L-glutamine Therapy for Sickle Cell Anemia medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as L-glutamine Therapy for Sickle Cell Anemia. L-glutamine Therapy for Sickle Cell Anemia Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a L-glutamine Therapy for Sickle Cell Anemia clinical trial. Participants frequently get the best healthcare available for their L-glutamine Therapy for Sickle Cell Anemia condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "L" Clinical Trials Conditions > L-glutamine Therapy for Sickle Cell Anemia  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. Bone Marrow transplant from related donor for patients with high risk hemoglobinopathies
3. Deferoxamine for the Treatment of Hemochromatosis
4. Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies
5. L-glutamine Therapy for Sickle Cell Anemia
Related Studies:
Other Anemia, Sickle Cell Clinical Trials
Other California Clinical Trials
Other Torrance Clinical Trials
L-glutamine Therapy for Sickle Cell Anemia
|
|
|
|
|
|
|
|
