Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131508
Status:
TERMINATED
Last Update Posted:
2017-04-26
First Post:
2005-08-17
Brief Title:
Trial of Oral Glutamine in Patients With Sickle Cell Anemia
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
A Randomized Controlled Trial of Oral Glutamine Supplementation Versus a Placebo Supplement in Children With Sickle Cell Anemia
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow participant accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
1 The study will 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
2 The study investigates the effect of oral glutamine and placebo on body composition in children with SCA by comparing the difference in body mass indexes BMIs and percent of body fat DEXA Scan between baseline and 12 months of treatment in the two groups
3 This Study will investigate the effect of oral glutamine and placebo on growth in children with SCA by comparing the Z scores for one year before baseline to 1 year while on study
4 This study will investigate the effect of oral glutamine and placebo in children with SCA by comparing the difference in the levels of plasma and red blood cell glutamine between baseline and 12 months of treatment in the two groups
5 This study will investigate the clinical effects strength and exercise endurance of oral glutamine and placebo in children with SCA by comparing the difference between baseline and 12 months of treatment in the two groups
6 This study will evaluate quality of life in children with SCA who have glutamine or placebo for 12 months
7 This study will evaluate the changes in REE over time in a small group of patients that will have REE measurement at months 3 6 and 9 This objective will be offered to all patients but will be additional studies that are not required to participate in the protocol
2 The study investigates the effect of oral glutamine and placebo on body composition in children with SCA by comparing the difference in body mass indexes BMIs and percent of body fat DEXA Scan between baseline and 12 months of treatment in the two groups
3 This Study will investigate the effect of oral glutamine and placebo on growth in children with SCA by comparing the Z scores for one year before baseline to 1 year while on study
4 This study will investigate the effect of oral glutamine and placebo in children with SCA by comparing the difference in the levels of plasma and red blood cell glutamine between baseline and 12 months of treatment in the two groups
5 This study will investigate the clinical effects strength and exercise endurance of oral glutamine and placebo in children with SCA by comparing the difference between baseline and 12 months of treatment in the two groups
6 This study will evaluate quality of life in children with SCA who have glutamine or placebo for 12 months
7 This study will evaluate the changes in REE over time in a small group of patients that will have REE measurement at months 3 6 and 9 This objective will be offered to all patients but will be additional studies that are not required to participate in the protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None