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L-Glutamine Therapy for Sickle Cell Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00586209
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
Sponsor:
Collaborator:
Emmaus Medical, Inc.
Information provided by (Responsible Party):
yutaka niihara, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Sickle Cell Anemia
Thalassemia
Interventions Drug: L-Glutamine
Drug: Placebo
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title L-glutamine Placebo
Hide Arm/Group 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

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)

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

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

Period Title: Overall Study
Started 5 10
Completed 5 10
Not Completed 0 0
Arm/Group Title L-glutamine Placebo Total
Hide Arm/Group 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

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)

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

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

Total of all reporting groups
Overall Number of Baseline Participants 5 10 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 10 participants 15 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
10
 100.0%
15
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 10 participants 15 participants
Female
3
  60.0%
5
  50.0%
8
  53.3%
Male
2
  40.0%
5
  50.0%
7
  46.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 10 participants 15 participants
5 10 15
1.Primary Outcome
Title Effect of L-glutamine Therapy on Exercise Endurance of Sickle Cell Anemia Patients
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated by the Sponsor's business decision prior to achieving the planned enrollment. Due to this the data was not collected and not analyzed. However safety data was collected and analyzed to gather data on the safety of L-glutamine in sickle cell patients.
Arm/Group Title L-glutamine Placebo
Hide Arm/Group 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

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)

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Effect of L-glutamine Therapy on Breath by Breath Exercise of Sickle Cell Patients
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated by the Sponsor's business decision prior to achieving the planned enrollment. Due to this the data was not collected and not analyzed. However safety data was collected and analyzed to gather data on the safety of L-glutamine in sickle cell patients.
Arm/Group Title L-glutamine Placebo
Hide Arm/Group 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

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)

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Effect of Oral L-glutamine on Incidence of Painful Crises
Hide Description Incidence of panful crises will be assessed at each visit.
Time Frame From Week 0 through Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated by the Sponsor's business decision prior to achieving the planned enrollment. Due to this the data was not collected and not analyzed. However safety data was collected and analyzed to gather data on the safety of L-glutamine in sickle cell patients.
Arm/Group Title L-glutamine Placebo
Hide Arm/Group 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

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)

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Effect of Oral L-glutamine on Amount of Daily Requirement for Narcotics
Hide Description Amount of daily requirement for narcotics will assessed at each visit.
Time Frame From Week 0 through Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated by the Sponsor's business decision prior to achieving the planned enrollment. Due to this the data was not collected and not analyzed. However safety data was collected and analyzed to gather data on the safety of L-glutamine in sickle cell patients.
Arm/Group Title L-glutamine Placebo
Hide Arm/Group 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

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)

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Effect of Oral L-glutamine on Level of Chronic Pain
Hide Description Level of chronic pain will be assessed at each visit.
Time Frame From Week 0 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated by the Sponsor's business decision prior to achieving the planned enrollment. Due to this the data was not collected and not analyzed. However safety data was collected and analyzed to gather data on the safety of L-glutamine in sickle cell patients.
Arm/Group Title L-glutamine Placebo
Hide Arm/Group 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

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)

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
Adverse Event Reporting Description The Safety population will include all patients who received at least one dose of study medication.
 
Arm/Group Title L-glutamine Placebo
Hide Arm/Group 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

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)

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

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

All-Cause Mortality
L-glutamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
L-glutamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/5 (40.00%)      5/10 (50.00%)    
Congenital, familial and genetic disorders     
Sickle cell anaemia with crisis  1  1/5 (20.00%)  1 4/10 (40.00%)  4
Investigations     
Haemoglobin decreased  1  0/5 (0.00%)  0 1/10 (10.00%)  1
Vascular disorders     
Hypertension  1  1/5 (20.00%)  1 0/10 (0.00%)  0
1
Term from vocabulary, MedDRA (7.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
L-glutamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/5 (80.00%)      7/10 (70.00%)    
Congenital, familial and genetic disorders     
Sickle cell anaemia with crisis  1  1/5 (20.00%)  1 4/10 (40.00%)  4
Gastrointestinal disorders     
Constipation  1  0/5 (0.00%)  0 1/10 (10.00%)  1
Diarrhoea  1  1/5 (20.00%)  1 0/10 (0.00%)  0
Mouth Pain  1  0/5 (0.00%)  0 1/10 (10.00%)  1
Nausea  1  1/5 (20.00%)  1 0/10 (0.00%)  0
Vomiting  1  1/5 (20.00%)  1 0/10 (0.00%)  0
General disorders     
Chest pain  1  0/5 (0.00%)  0 1/10 (10.00%)  1
Infections and infestations     
Clostridium difficile colitis  1  0/5 (0.00%)  0 1/10 (10.00%)  1
Fungal infection  1  1/5 (20.00%)  1 0/10 (0.00%)  0
Nasopharyngitis  1  1/5 (20.00%)  1 1/10 (10.00%)  1
Investigations     
Cardiac murmur  1  1/5 (20.00%)  1 0/10 (0.00%)  0
Haemoglobin decreased  1  0/5 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/5 (0.00%)  0 1/10 (10.00%)  1
Back pain  1  0/5 (0.00%)  0 1/10 (10.00%)  1
Nervous system disorders     
Headache  1  0/5 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/5 (20.00%)  1 0/10 (0.00%)  0
Cough  1  1/5 (20.00%)  1 0/10 (0.00%)  0
Surgical and medical procedures     
Endodontic procedure  1  0/5 (0.00%)  0 1/10 (10.00%)  1
Vascular disorders     
Hypertension  1  1/5 (20.00%)  1 0/10 (0.00%)  0
1
Term from vocabulary, MedDRA (7.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Yutaka Niihara, MD, MPH
Organization: Emmaus Medical, Inc.
Phone: 310-214-0065
EMail: yniihara@emmausmedical.com
Layout table for additonal information
Responsible Party: yutaka niihara, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT00586209    
Other Study ID Numbers: 10511-01RY
First Submitted: December 21, 2007
First Posted: January 4, 2008
Results First Submitted: September 21, 2020
Results First Posted: February 2, 2021
Last Update Posted: February 2, 2021