Trial of Oral Glutamine in Patients With Sickle Cell Anemia

This study has been terminated.
(Due to slow participant accrual)
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00131508
First received: August 17, 2005
Last updated: May 18, 2010
Last verified: March 2010
Results First Received: February 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Anemia, Sickle Cell
Interventions: Drug: Glutamine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
27 participants were recruited from July, 2004 through October, 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
25 of the 27 participants were randomized to either the Glutamine or Placebo arm.

Reporting Groups
  Description
Placebo A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.

Participant Flow:   Overall Study
    Placebo     Glutamine  
STARTED     12     13  
COMPLETED     9     5  
NOT COMPLETED     3     8  
Disease progression                 0                 2  
Non-Compliance                 2                 4  
Withdrawal by Subject                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo A mixture of non-essential amino acids containing glycine, alanine, and serine.
Glutamine Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
Total Total of all reporting groups

Baseline Measures
    Placebo     Glutamine     Total  
Number of Participants  
[units: participants]
  12     13     25  
Age  
[units: years]
Mean ± Standard Deviation
  9.1  ± 2.9     9.1  ± 3.6     9.1  ± 3.2  
Gender  
[units: participants]
     
Female     6     9     15  
Male     6     4     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Resting Energy Expenditure From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]

2.  Secondary:   Change in Body Mass Index From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]

3.  Secondary:   Change in Red Blood Cell Glutamine From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]

4.  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.   [ Time Frame: Baseline and 12 Months ]

5.  Secondary:   Change in Height Z-score From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]

6.  Secondary:   Change in Height Percentile From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]

7.  Secondary:   Change in Weight Percentile From Baseline to 12 Months   [ Time Frame: Basline and 12 months ]

8.  Secondary:   Change in Pulse Rate From Baseline to 12 Months   [ Time Frame: Baseline and 12 months ]

9.  Secondary:   Change in Hand Grip From Baseline to 12 Months.   [ Time Frame: Baseline and 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Winfred Wang
Organization: St Jude Children's Research Hospital
phone: 1-866-278-5833
e-mail: info@stjude.org


No publications provided


Responsible Party: Ruth Williams, MS, RD, EdD, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00131508     History of Changes
Other Study ID Numbers: SCGLU2
Study First Received: August 17, 2005
Results First Received: February 19, 2010
Last Updated: May 18, 2010
Health Authority: United States: Institutional Review Board