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Trial of Oral Glutamine in Patients with Sickle Cell Anemia - Article


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Sickle Cell Anemia

Hb S disease; Hemoglobin S Disease; Herrick's anemia; SCD 




Clinical Trial: Trial of Oral Glutamine in Patients with Sickle Cell Anemia

This study is currently recruiting patients.
Verified by St. Jude Children''''s Research Hospital August 2005

Sponsored by: St. Jude Children''''s Research Hospital
Information provided by: St. Jude Children''''s Research Hospital
ClinicalTrials.gov Identifier: NCT00131508

Purpose

Children with sickle cell anemia 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
Phase II

MedlinePlus related topics:  Sickle Cell Anemia
Genetics Home Reference related topics:  sickle cell anemia

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, 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

Further Study Details: 
Primary Outcomes: To find out the effect of treatment with glutamine on the energy level of children with SCA; To find out the effects of glutamine on growth, muscle strength, and exercise endurance in children with SCA; To find out if treatment with glutamine affects the quality of life of children with SCA
Expected Total Enrollment:  46

Study start: May 2004

Eligibility

Ages Eligible for Study:  5 Years   -   18 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Must be actively receiving medical care for sickle cell anemia at St. Jude Children''''s Research Hospital
  • Must be age 5 years through 18 years
  • Must have adequate renal (kidney) and hepatic (liver) function

Exclusion Criteria:

-

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00131508

Ruth Williams, MS, RD, EdD      1-866-278-5833    info@stjude.org

Tennessee
      St. Jude Children''''s Research Hospital, Memphis,  Tennessee,  38105,  United States; Recruiting
Ruth Williams, MS,RD,EdD  866-278-5833    info@stjude.org 

Study chairs or principal investigators

Ruth Williams, MS, RD, EdD,  Principal Investigator,  St. Jude Children''''s Research Hospital   

More Information

St. Jude Children''''s Research Hospital

Study ID Numbers:  SCGLU2
Last Updated:  August 17, 2005
Record first received:  August 17, 2005
ClinicalTrials.gov Identifier:  NCT00131508
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-23

Resources



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November 29, 2009



Page Updated: October 15, 2009
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