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Due to slow participant accrual
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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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Children with sickle cell anemia (SCA) seem to have higher energy needs than children who do not have the disease. This may be the reason why children and teenagers with sickle cell anemia tend to be smaller, weigh less, and have less fat and muscle than children and teens that do not have the disease.
This study is being done to find out if giving a supplement called glutamine will help children with sickle cell anemia by lowering their energy needs and improving their growth and strength. Children will be randomly assigned (like a flip of a coin) to one of two groups. One group will take glutamine and one group will take a placebo (a protein mixture that looks like glutamine but may not have the same effect in the body). No one will know which group is taking which supplement until the study has been completed. Children will be in the study for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | Glutamine |
|
| 1 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutamine | Drug | 0.6 gm/kg of oral glutamine per day, in two doses for one year. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting Energy Expenditure From Baseline to 12 Months | 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. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index From Baseline to 12 Months | 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. | Baseline and 12 months |
| Change in Red Blood Cell Glutamine From Baseline to 12 Months |
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Inclusion Criteria:
Active patient (presently receiving medical care for SCA) at the St. Jude Comprehensive Sickle Cell Center (SJCSCC) or an affiliate or alliance of St Jude. Patient must not be in the high risk category as defined by the SJCSCC. High risk is defined as follows:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Williams, MS, RD, EdD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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25 of the 27 participants were randomized to either the Glutamine or Placebo arm.
27 participants were recruited from July, 2004 through October, 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | A mixture of non-essential amino acids containing glycine, alanine, and serine. |
| FG001 | Glutamine | Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | A mixture of non-essential amino acids containing glycine, alanine, and serine. |
| BG001 | Glutamine | Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Resting Energy Expenditure From Baseline to 12 Months | 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. | Posted | Median | Full Range | REE ratio | Baseline and 12 months |
|
Baseline through 12 months for an average of one year.
Patients were monitored for adverse events throughout the entire course of the study from baseline through 12 months for an average of one year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | A mixture of non-essential amino acids containing glycine, alanine, and serine. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Winfred Wang | St Jude Children's Research Hospital | 1-866-278-5833 | info@stjude.org |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Placebo |
| Drug |
Placebo |
|
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. |
| Baseline and 12 months |
| 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. | 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. | Baseline and 12 Months |
| Change in Height Z-score From Baseline to 12 Months | 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. | Baseline and 12 months |
| Change in Height Percentile From Baseline to 12 Months | 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. | Baseline and 12 months |
| Change in Weight Percentile From Baseline to 12 Months | 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. | Basline and 12 months |
| Change in Pulse Rate From Baseline to 12 Months | 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. | Baseline and 12 months |
| Change in Hand Grip From Baseline to 12 Months. | 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). | Baseline and 12 months |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Glutamine |
Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses. |
|
|
|
| Secondary | Change in Body Mass Index From Baseline to 12 Months | 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. | Posted | Median | Full Range | kg/m2 | Baseline and 12 months |
|
|
|
|
| Secondary | Change in Red Blood Cell Glutamine From Baseline to 12 Months | 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. | Posted | Median | Full Range | nmol/mg creatinine | Baseline and 12 months |
|
|
|
|
| Secondary | 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. | 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. | Posted | Median | Full Range | Units on a scale | Baseline and 12 Months |
|
|
|
|
| Secondary | Change in Height Z-score From Baseline to 12 Months | 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. | Analyzed patients had a height measurement at both baseline and 12 months. | Posted | Median | Full Range | Z-score | Baseline and 12 months |
|
|
|
|
| Secondary | Change in Height Percentile From Baseline to 12 Months | 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. | Analyzed patients had a height measurement at both baseline and 12 months. | Posted | Median | Full Range | Percentile | Baseline and 12 months |
|
|
|
|
| Secondary | Change in Weight Percentile From Baseline to 12 Months | 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. | Analyzed patients had a height measurement at both baseline and 12 months. | Posted | Median | Full Range | Percentile | Basline and 12 months |
|
|
|
|
| Secondary | Change in Pulse Rate From Baseline to 12 Months | 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. | Analyzed patients had a height measurement at both baseline and 12 months. | Posted | Median | Full Range | Beats per minute (BPM) | Baseline and 12 months |
|
|
|
|
| Secondary | Change in Hand Grip From Baseline to 12 Months. | 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). | Analyzed patients had a height measurement at both baseline and 12 months. | Posted | Median | Full Range | kg | Baseline and 12 months |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Glutamine | Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses. | 0 | 13 | 0 | 13 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D021542 | Amino Acids, Neutral |
| Baseline Parent Reported Social Function |
|
| Baseline Parent Reported School Function |
|
| 12 Months Parent Reported Physical Function |
|
| 12 Months Parent Reported Emotional Function |
|
| 12 Months Parent Reported Social Function |
|
| 12 Months Parent Reported School Function |
|
| Baseline Participant Reported Physical Function |
|
| Baseline Participant Reported Emotional Function |
|
| Baseline Participant Reported Social Function |
|
| Baseline Participant Reported School Function |
|
| 12 Months Participant Reported Physical Function |
|
| 12 Months Participant Reported Emotional Function |
|
| 12 Months Participant Reported Social Function |
|
| 12 Months Participant Reported School Function |
|
| Wilcoxon (Mann-Whitney) |
| 0.14 |
| 95 |
| Superiority or Other |
| We tested for a significant difference in the median change between baseline parent reported social function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.20 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between baseline parent reported school function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.62 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between 12 month parent reported physical function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.61 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between 12 month parent reported emotional function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.65 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between 12 month parent reported social function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.55 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between 12 month parent reported school function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.69 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between baseline patient reported physical function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.82 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between baseline patient reported emotional function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.99 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between baseline patient reported social function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.30 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between baseline patient reported school function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.24 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between 12 month patient reported physical function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.50 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between 12 month patient reported emotional function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.45 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between 12 month patient reported social function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.46 | 95 | Superiority or Other |
| We tested for a significant difference in the median change between 12 month patient reported school function in the placebo and glutamine groups. | Wilcoxon (Mann-Whitney) | 0.84 | 95 | Superiority or Other |
| Wilcoxon Signed Rank Test |
| 0.81 |
| 95 |
| Superiority or Other |
| 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. | Wilcoxon (Mann-Whitney) | 0.70 | 95 | Superiority or Other |
| Wilcoxon Signed Rank Test |
| 0.75 |
| 95 |
| Superiority or Other |
| We test the null hypothesis that the median difference in height percentile between baseline and 12 months differs between the Glutamine and Placebo groups. | Wilcoxon (Mann-Whitney) | 0.93 | 95 | Superiority or Other |
| Wilcoxon Signed Rank Test |
| 1.0 |
| 95 |
| Superiority or Other |
| We test the null hypothesis that the median difference in weight percentile between baseline and 12 months differs between the Glutamine and Placebo groups. | Wilcoxon (Mann-Whitney) | 0.61 | 95 | Superiority or Other |