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| Sponsors and Collaborators: |
St. Jude Children's Research Hospital Thrasher Research Fund |
|---|---|
| Information provided by: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00131508 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia, Sickle Cell |
Drug: Glutamine Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Controlled Trial of Oral Glutamine Supplementation Versus a Placebo Supplement in Children With Sickle Cell Anemia |
| Estimated Enrollment: | 46 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
2: Experimental
Glutamine
|
Drug: Glutamine
0.6 gm/kg of oral glutamine per day, in two doses for one year.
|
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1: Placebo Comparator
N/A
|
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 5 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
| Principal Investigator: | Ruth Williams, MS, RD, EdD | St. Jude Children's Research Hospital |
More Information
| Responsible Party: | St. Jude Children's Research Hospital ( Ruth Williams, MS, RD, EdD ) |
| Study ID Numbers: | SCGLU2 |
| Study First Received: | August 17, 2005 |
| Last Updated: | September 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00131508 |
| Health Authority: | United States: Institutional Review Board |
|
Hemoglobin S Disease Sickle Cell Anemia |
|
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Anemia |
Anemia, Hemolytic Hemoglobinopathy Anemia, Sickle Cell Sickle cell anemia |
