L-Glutamine Therapy for Sickle Cell Anemia

Sickle Cell Anemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00586209
• Other study ID #: 10511-01RY
• Status: Terminated
• Phase: Phase 2
• Start date: February 6, 2004
• Est. completion date: November 2009

Study information

• Verified date: February 2021
• Source: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: November 2009
• Est. primary completion date: August 27, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Sickle Cell Anemia
• Thalassemia

Intervention

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)
• Placebo
Placebo (75% Maltodextrin, 24.5 % Starch, 0.5% Tricalcium Phosphate) - given at the same dosage as L-glutamine

Locations

Country	Name	City	State
United States	LA Biomed at Harbor-UCLA Medical Center	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Emmaus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, Weeks 8 and 12
Primary	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	Baseline, Weeks 18 and 12
Secondary	Effect of Oral L-glutamine on Incidence of Painful Crises	Incidence of panful crises will be assessed at each visit.	From Week 0 through Week 12
Secondary	Effect of Oral L-glutamine on Amount of Daily Requirement for Narcotics	Amount of daily requirement for narcotics will assessed at each visit.	From Week 0 through Week 20
Secondary	Effect of Oral L-glutamine on Level of Chronic Pain	Level of chronic pain will be assessed at each visit.	From Week 0 to Week 12