Back to resultsL-Glutamine Therapy for Sickle Cell Anemia
Primary Purpose
Sickle Cell Anemia, Thalassemia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
L-Glutamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Anemia focused on measuring sickle cell disease, sickle cell anemia, L-glutamine, Sickle Cell Anemia (homozygous), Sickle β°-Thalassemia
Eligibility Criteria
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.
Sites / Locations
- LA Biomed at Harbor-UCLA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
L-glutamine
Placebo
Arm Description
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
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
Outcomes
Primary Outcome Measures
Effect of L-glutamine Therapy on Exercise Endurance of Sickle Cell Anemia Patients
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
Breath by breath exercise will be examined at each visit. Change from baseline will be reported at weeks 8 and 12
Secondary Outcome Measures
Effect of Oral L-glutamine on Incidence of Painful Crises
Incidence of panful crises will be assessed at each visit.
Effect of Oral L-glutamine on Amount of Daily Requirement for Narcotics
Amount of daily requirement for narcotics will assessed at each visit.
Effect of Oral L-glutamine on Level of Chronic Pain
Level of chronic pain will be assessed at each visit.
Full Information
NCT ID
NCT00586209
First Posted
December 21, 2007
Last Updated
February 1, 2021
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
Emmaus Medical, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00586209
Brief Title
L-Glutamine Therapy for Sickle Cell Anemia
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Inadequate clinical supplies and Emmaus business decision.
Study Start Date
February 6, 2004 (Actual)
Primary Completion Date
August 27, 2008 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
Emmaus Medical, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Anemia, Thalassemia
Keywords
sickle cell disease, sickle cell anemia, L-glutamine, Sickle Cell Anemia (homozygous), Sickle β°-Thalassemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-glutamine
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
L-Glutamine
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine
Primary Outcome Measure Information:
Title
Effect of L-glutamine Therapy on Exercise Endurance of Sickle Cell Anemia Patients
Description
Exercise endurance will be examined at each visit. Change from baseline will be reported at weeks 8 and 12
Time Frame
Baseline, Weeks 8 and 12
Title
Effect of L-glutamine Therapy on Breath by Breath Exercise of Sickle Cell Patients
Description
Breath by breath exercise will be examined at each visit. Change from baseline will be reported at weeks 8 and 12
Time Frame
Baseline, Weeks 18 and 12
Secondary Outcome Measure Information:
Title
Effect of Oral L-glutamine on Incidence of Painful Crises
Description
Incidence of panful crises will be assessed at each visit.
Time Frame
From Week 0 through Week 12
Title
Effect of Oral L-glutamine on Amount of Daily Requirement for Narcotics
Description
Amount of daily requirement for narcotics will assessed at each visit.
Time Frame
From Week 0 through Week 20
Title
Effect of Oral L-glutamine on Level of Chronic Pain
Description
Level of chronic pain will be assessed at each visit.
Time Frame
From Week 0 to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yutaka Niihara, MD
Organizational Affiliation
LaBiomed At Harbor-UCLA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
LA Biomed at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
12. IPD Sharing Statement
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L-Glutamine Therapy for Sickle Cell Anemia
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