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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Oral Glutamine Supplementation Versus a Placebo Supplement in Children With Sickle Cell Anemia

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Change in Resting Energy Expenditure From Baseline to 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Body Mass Index From Baseline to 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.

  • Change in Red Blood Cell Glutamine From Baseline to 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Change in Height Z-score From Baseline to 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.

  • Change in Height Percentile From Baseline to 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.

  • Change in Weight Percentile From Baseline to 12 Months [ Time Frame: Basline and 12 months ] [ Designated as safety issue: No ]
    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.

  • Change in Pulse Rate From Baseline to 12 Months [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.

  • Change in Hand Grip From Baseline to 12 Months. [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

    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).



Enrollment: 27
Study Start Date: May 2004
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2
Glutamine
Drug: Glutamine
0.6 gm/kg of oral glutamine per day, in two doses for one year.
Placebo Comparator: 1
N/A
Drug: Placebo
Placebo

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.
  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 3 or more admissions and/or emergency department visits for pain within the past 12 months, or;
  • 2 or more episodes of acute chest syndrome within the past 24 months, or;
  • A combination of pain and ACS events > 3 within the past 12 months.
  • 5-18 years of age
  • Diagnosis of Hb SS or HB0Thal
  • Weight >15 kg
  • <50th percentile for height/age or weight/age or weight/ height, or <90% ideal body weight, or <90% of BMI for age/ gender.
  • Is willing to sign informed consent

Exclusion Criteria

  • Patients receiving hydroxyurea or any other anti-sickling agent, chronic transfusion, or nutrition supplements.A nutrition supplement is any high calorie or high protein food additive or oral supplement being used for the purpose of weight gain.
  • History of poor compliance (Missing two or more clinic appointments in the past year).
  • Renal or liver dysfunction
  • Renal dysfunction as defined by serum creatinine >1.5 times normal for age based on testing lab.
  • Hepatic dysfunction as defined by alanine aminotransferase (ALT) >2 times the upper limit of normal for age based on testing lab.
  • Breastfeeding
  • Pregnancy.Females of childbearing potential must have negative serum or urine pregnancy test (record date of test).
  • Patients enrolled on previous glutamine protocol (SCDGLU).
  • Patients who are considered high risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131508

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Thrasher Research Fund
Investigators
Principal Investigator: Ruth Williams, MS, RD, EdD St. Jude Children's Research Hospital
  More Information

Additional Information:
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

Keywords provided by St. Jude Children's Research Hospital:
Hemoglobin S Disease
Sickle Cell Anemia

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 27, 2014