Trial Outcomes & Findings for L-Glutamine Therapy for Sickle Cell Anemia (NCT NCT00586209)
NCT ID: NCT00586209
Last Updated: 2021-02-02
Results Overview
Exercise endurance will be examined at each visit. Change from baseline will be reported at weeks 8 and 12
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Baseline, Weeks 8 and 12
Results posted on
2021-02-02
Participant Flow
Participant milestones
| Measure |
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
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
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 Study
STARTED
|
5
|
10
|
|
Overall Study
COMPLETED
|
5
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
L-Glutamine Therapy for Sickle Cell Anemia
Baseline characteristics by cohort
| Measure |
L-glutamine
n=5 Participants
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)
|
Placebo
n=10 Participants
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
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
10 participants
n=4 Participants
|
15 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 8 and 12Population: 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.
Exercise endurance will be examined at each visit. Change from baseline will be reported at weeks 8 and 12
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, Weeks 18 and 12Population: 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.
Breath by breath exercise will be examined at each visit. Change from baseline will be reported at weeks 8 and 12
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 0 through Week 12Population: 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.
Incidence of panful crises will be assessed at each visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 0 through Week 20Population: 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.
Amount of daily requirement for narcotics will assessed at each visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 0 to Week 12Population: 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.
Level of chronic pain will be assessed at each visit.
Outcome measures
Outcome data not reported
Adverse Events
L-glutamine
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
L-glutamine
n=5 participants at risk
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)
|
Placebo
n=10 participants at risk
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
|
|---|---|---|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
40.0%
4/10 • Number of events 4 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
0.00%
0/10 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
Other adverse events
| Measure |
L-glutamine
n=5 participants at risk
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)
|
Placebo
n=10 participants at risk
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
|
|---|---|---|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
40.0%
4/10 • Number of events 4 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/5 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
0.00%
0/10 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Mouth Pain
|
0.00%
0/5 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
0.00%
0/10 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
0.00%
0/10 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/5 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/5 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Infections and infestations
Fungal infection
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
0.00%
0/10 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Investigations
Cardiac murmur
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
0.00%
0/10 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
0.00%
0/10 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
0.00%
0/10 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/5 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
10.0%
1/10 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Number of events 1 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
0.00%
0/10 • Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
The Safety population will include all patients who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place