L-Glutamine Therapy for Sickle Cell Anemia
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| ClinicalTrials.gov Identifier: NCT00586209 |
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Recruitment Status :
Terminated
(Inadequate clinical supplies and Emmaus business decision.)
First Posted : January 4, 2008
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
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The primary purpose is to evaluate the effect of L-glutamine therapy on exercise endurance and breath by breath exercise response of sickle cell anemia patients
The secondary purpose is to assess the effect of L-glutamine on incidence of painful crises; level of chronic pain, and amount of daily requirement for narcotics.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sickle Cell Anemia Thalassemia | Drug: L-Glutamine Drug: Placebo | Phase 2 |
This is a phase II, prospective, randomized, double-blind, placebo-controlled, parallel-group,study to evaluate the safety and efficacy of oral L-glutamine therapy for patients with sickle cell anemia or sickle β°-thalassemia who are at least 18 years old with focus on the aspect of exercise endurance. In this study, the patients will orally take L-glutamine or placebo twice daily, and clinical and hematological parameters will be monitored. The adverse events,especially those attributable to L-glutamine therapy, will also be monitored.
The data obtained will be essential in understanding the role of L-glutamine in therapy for sickle cell anemia and sickle β°-thalassemia.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 15 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Study of L Glutamine Therapy for Sickle Cell Anemia and Sickle ß0-Thalassemia |
| Actual Study Start Date : | February 6, 2004 |
| Actual Primary Completion Date : | August 27, 2008 |
| Actual Study Completion Date : | November 2009 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: L-glutamine
L-glutamine group will be given at the following dosage: 17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily |
Drug: L-Glutamine
L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (>66.7 kg) |
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Placebo Comparator: Placebo
Maltodextrin group will be given at the following dosage: 17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily |
Drug: Placebo
Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine |
- Effect of L-glutamine Therapy on Exercise Endurance of Sickle Cell Anemia Patients [ Time Frame: Baseline, Weeks 8 and 12 ]Exercise endurance will be examined at each visit. Change from baseline will be reported at weeks 8 and 12
- Effect of L-glutamine Therapy on Breath by Breath Exercise of Sickle Cell Patients [ Time Frame: Baseline, Weeks 18 and 12 ]Breath by breath exercise will be examined at each visit. Change from baseline will be reported at weeks 8 and 12
- Effect of Oral L-glutamine on Incidence of Painful Crises [ Time Frame: From Week 0 through Week 12 ]Incidence of panful crises will be assessed at each visit.
- Effect of Oral L-glutamine on Amount of Daily Requirement for Narcotics [ Time Frame: From Week 0 through Week 20 ]Amount of daily requirement for narcotics will assessed at each visit.
- Effect of Oral L-glutamine on Level of Chronic Pain [ Time Frame: From Week 0 to Week 12 ]Level of chronic pain will be assessed at each visit.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible to participate in the study, a patient must meet all of the following inclusion criteria:
- Patient is at least 18 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.
- Patient is able to perform exercise tolerance test
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586209
| United States, California | |
| LA Biomed at Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90502 | |
| Principal Investigator: | Yutaka Niihara, MD | LaBiomed At Harbor-UCLA Medical Center |
| Responsible Party: | yutaka niihara, President, Emmaus Medical, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
| ClinicalTrials.gov Identifier: | NCT00586209 |
| Other Study ID Numbers: |
10511-01RY |
| First Posted: | January 4, 2008 Key Record Dates |
| Results First Posted: | February 2, 2021 |
| Last Update Posted: | February 2, 2021 |
| Last Verified: | February 2021 |
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sickle cell disease sickle cell anemia L-glutamine Sickle Cell Anemia (homozygous) Sickle β°-Thalassemia |
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Anemia Thalassemia Anemia, Sickle Cell Hematologic Diseases |
Anemia, Hemolytic, Congenital Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn |