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Trial record 18 of 28 for:    sickle cell | "Sickle Cell Trait"

Trial of Oral Glutamine in Patients With Sickle Cell Anemia

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ClinicalTrials.gov Identifier: NCT00131508
Recruitment Status : Terminated (Due to slow participant accrual)
First Posted : August 18, 2005
Results First Posted : May 12, 2010
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Anemia, Sickle Cell
Interventions Drug: Glutamine
Drug: Placebo
Enrollment 27
Recruitment Details 27 participants were recruited from July, 2004 through October, 2007.
Pre-assignment Details 25 of the 27 participants were randomized to either the Glutamine or Placebo arm.
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description A mixture of non-essential amino acids containing glycine, alanine, and serine. Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Period Title: Overall Study
Started 12 13
Completed 9 5
Not Completed 3 8
Reason Not Completed
Disease progression             0             2
Non-Compliance             2             4
Withdrawal by Subject             1             2
Arm/Group Title Placebo Glutamine Total
Hide Arm/Group Description A mixture of non-essential amino acids containing glycine, alanine, and serine. Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses. Total of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
9.1  (2.9) 9.1  (3.6) 9.1  (3.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
6
  50.0%
9
  69.2%
15
  60.0%
Male
6
  50.0%
4
  30.8%
10
  40.0%
1.Primary Outcome
Title Change in Resting Energy Expenditure From Baseline to 12 Months
Hide Description To compare the effect of glutamine and placebo on resting energy expenditure (REE) in children with sickle cell anemia (SCA) by comparing the change in REE ratio between baseline and 12 months. REE was measured by indirect calorimetry, using a metabolic cart.REE Ratio =(REE Measured/REE Predicted)x 100).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.The REE Ratio was evaluated at baseline and 12 months.The REE Ratio is calculated as (REE Measured / REE Predicted) x 100).REE units are measured as (Kcal / day).Change was defined as 12 Month REE Ratio minus Baseline REE Ratio.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description:
A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Overall Number of Participants Analyzed 12 13
Median (Full Range)
Unit of Measure: REE ratio
-5.5
(-37.6 to 12.2)
7.1
(-9.0 to 41.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change in REE ratio between the placebo and glutamine groups. The study was designed to provide 80% power at an alpha level of 0.05 for this objective. Due to slow accrual, the sample size of 46 participants required to obtain the designed power of the study was not realized.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in Body Mass Index From Baseline to 12 Months
Hide Description To investigate the effect of oral glutamine and placebo on body composition in children with SCA by comparing the difference in body mass indexes (BMI) between baseline and 12 months of treatment in the two groups.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description:
A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Overall Number of Participants Analyzed 12 13
Median (Full Range)
Unit of Measure: kg/m2
0.1
(-0.3 to 1.2)
0.8
(-0.6 to 0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change of body mass index between the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Change in Red Blood Cell Glutamine From Baseline to 12 Months
Hide Description To investigate the effect of oral glutamine and placebo in children with Sickle Cell Anemia (SCA) by comparing the difference in the levels of red blood cell glutamine between baseline and 12 months of treatment in the two groups.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description:
A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Overall Number of Participants Analyzed 12 13
Median (Full Range)
Unit of Measure: nmol/mg creatinine
43.5
(-173.9 to 137.0)
100.8
(21.1 to 262.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change in red blood cell glutamine between the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Change in Quality of Life Measures From Baseline to 12 Months.Scores for Each Subcategory Range From 0 (Best) to 4 (Worst).This is True for Both Patient and Parent Reports.
Hide Description Evaluation of quality of life at baseline and 12 months in the glutamine versus placebo group using the PedsQL Version 4.0 inventory. This instrument measures individual well being across physical, emotional, social, and school function categories using patient self-reports and/or parent reports. The tool contains a 15-question, age-specific, self-report inventory (for children age 5-7 years, 8-12 years, and 13-18 years) and a corresponding parent inventory. Lower scores indicate a better quality of life.
Time Frame Baseline and 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description:
A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Overall Number of Participants Analyzed 12 13
Median (Full Range)
Unit of Measure: Units on a scale
Baseline Parent Reported Physical Function
1.4
(0.3 to 3.5)
2.0
(0.0 to 2.9)
Baseline Parent Reported Emotional Function
1.0
(0.0 to 2.0)
2.0
(0.0 to 4.0)
Baseline Parent Reported Social Function
0.6
(0.0 to 2.6)
1.8
(0.0 to 3.0)
Baseline Parent Reported School Function
1.8
(0.8 to 2.6)
2.0
(0.0 to 3.6)
12 Months Parent Reported Physical Function
2.5
(0.3 to 3.3)
2.1
(0.5 to 2.9)
12 Months Parent Reported Emotional Function
1.4
(0.0 to 2.0)
1.2
(0.0 to 2.2)
12 Months Parent Reported Social Function
2.0
(0.0 to 2.8)
1.2
(0.4 to 2.4)
12 Months Parent Reported School Function
1.8
(0.4 to 3.2)
2.4
(1.6 to 3.8)
Baseline Participant Reported Physical Function
0.9
(0.4 to 2.8)
1.0
(0.1 to 2.0)
Baseline Participant Reported Emotional Function
0.8
(0.0 to 2.6)
1.2
(0.0 to 2.0)
Baseline Participant Reported Social Function
1.0
(0.0 to 2.0)
1.2
(0.0 to 2.8)
Baseline Participant Reported School Function
1.6
(0.8 to 2.8)
1.3
(0.0 to 2.4)
12 Months Participant Reported Physical Function
1.0
(0.5 to 2.1)
1.0
(0.6 to 2.9)
12 Months Participant Reported Emotional Function
0.8
(0.0 to 2.0)
1.2
(0.0 to 3.6)
12 Months Participant Reported Social Function
1.2
(0.4 to 2.2)
1.0
(0.0 to 3.6)
12 Months Participant Reported School Function
1.6
(1.0 to 3.2)
1.8
(1.0 to 3.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between baseline parent reported physical function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between baseline parent reported emotional function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between baseline parent reported social function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between baseline parent reported school function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between 12 month parent reported physical function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between 12 month parent reported emotional function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between 12 month parent reported social function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between 12 month parent reported school function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between baseline patient reported physical function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between baseline patient reported emotional function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between baseline patient reported social function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between baseline patient reported school function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between 12 month patient reported physical function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between 12 month patient reported emotional function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between 12 month patient reported social function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change between 12 month patient reported school function in the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change in Height Z-score From Baseline to 12 Months
Hide Description To investigate the effect of oral glutamine and placebo on height Z-score in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed patients had a height measurement at both baseline and 12 months.
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description:
A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Overall Number of Participants Analyzed 9 5
Median (Full Range)
Unit of Measure: Z-score
-0.1
(-52.2 to 0.4)
0.0
(-0.2 to 0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glutamine
Comments We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested the null hypothesis that the median difference in height Z-Score betweeen baseline and 12 months differs between the Glutamine and Placebo groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Change in Height Percentile From Baseline to 12 Months
Hide Description To investigate the effect of oral glutamine and placebo on height percentile in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed patients had a height measurement at both baseline and 12 months.
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description:
A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Overall Number of Participants Analyzed 9 5
Median (Full Range)
Unit of Measure: Percentile
0.0
(-12.5 to 20.0)
0.0
(-12.5 to 14.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glutamine
Comments We tested the null hypothesis that the median difference in height percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We test the null hypothesis that the median difference in height percentile between baseline and 12 months differs between the Glutamine and Placebo groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Change in Weight Percentile From Baseline to 12 Months
Hide Description To investigate the effect of oral glutamine and placebo on weight in children with Sickle Cell Anemia (SCA) between baseline and 12 months on treatment.
Time Frame Basline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed patients had a height measurement at both baseline and 12 months.
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description:
A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Overall Number of Participants Analyzed 9 5
Median (Full Range)
Unit of Measure: Percentile
0.0
(-11.0 to 12.5)
7.5
(-12.5 to 12.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Glutamine
Comments We tested the null hypothesis that the median difference in weight percentile between baseline and 12 months is equal to zero versus the alternative hypothesis that the difference is not zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Wilcoxon Signed Rank Test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We test the null hypothesis that the median difference in weight percentile between baseline and 12 months differs between the Glutamine and Placebo groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Change in Pulse Rate From Baseline to 12 Months
Hide Description To investigate the clinical effects of oral glutamine and placebo on pulse rate in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups.
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed patients had a height measurement at both baseline and 12 months.
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description:
A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Overall Number of Participants Analyzed 7 3
Median (Full Range)
Unit of Measure: Beats per minute (BPM)
11
(-22 to 44)
17
(-16 to 34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change in pulse rate between the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Change in Hand Grip From Baseline to 12 Months.
Hide Description

To investigate the clinical effects of oral glutamine and placebo on hand grip in children with Sickle Cell Anemia (SCA) by comparing the difference between baseline and 12 months of treatment between the two groups.

Hand grip strength is a measure of muscle strength.Units are measured in Kg.Muscle strength is measured using a hydraulic hand-held dynamometer.Change was defined as 12 Month measure minus baseline.Muscle strength is measured using the hand grip strength via a hydraulic hand-held dynamometer (Kg).

Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed patients had a height measurement at both baseline and 12 months.
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description:
A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Overall Number of Participants Analyzed 6 3
Median (Full Range)
Unit of Measure: kg
12
(-3 to 19)
5
(3 to 12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Glutamine
Comments We tested for a significant difference in the median change in hand grip between the placebo and glutamine groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Baseline through 12 months for an average of one year.
Adverse Event Reporting Description Patients were monitored for adverse events throughout the entire course of the study from baseline through 12 months for an average of one year.
 
Arm/Group Title Placebo Glutamine
Hide Arm/Group Description A mixture of non-essential amino acids containing glycine, alanine, and serine. Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
All-Cause Mortality
Placebo Glutamine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Glutamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Glutamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/13 (0.00%) 
The study was designed to enroll 46 participants (23 per arm). Due to slow accrual the study was terminated after enrolling 27 participants. Of the 27 participants enrolled, 2 dropped out of the study prior to randomization.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Winfred Wang
Organization: St Jude Children's Research Hospital
Phone: 1-866-278-5833
EMail: info@stjude.org
Layout table for additonal information
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00131508     History of Changes
Other Study ID Numbers: SCGLU2
First Submitted: August 17, 2005
First Posted: August 18, 2005
Results First Submitted: February 19, 2010
Results First Posted: May 12, 2010
Last Update Posted: April 26, 2017