Trial of Oral Glutamine in Patients With Sickle Cell Anemia

NCT00131508 | Terminated Phase 2 Results DMC

• 1 other identifier: SCGLU2
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Sickle Cell

Keywords

Hemoglobin S Disease; Sickle Cell Anemia

Outcome Measures

Primary Outcomes (1)

• Change in Resting Energy Expenditure From Baseline to 12 Months

  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.

  Baseline and 12 months

Secondary Outcomes (8)

• Change in Body Mass Index From Baseline to 12 Months

  Baseline and 12 months

• Change in Red Blood Cell Glutamine From Baseline to 12 Months

  Baseline and 12 months

• 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.

  Baseline and 12 Months

• Change in Height Z-score From Baseline to 12 Months

  Baseline and 12 months

• Change in Height Percentile From Baseline to 12 Months

  Baseline and 12 months

Study Arms (2)

2

EXPERIMENTAL

Glutamine

Drug: Glutamine

1

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Glutamine DRUG

0.6 gm/kg of oral glutamine per day, in two doses for one year.

2

Placebo DRUG

Placebo

1

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• or more admissions and/or emergency department visits for pain within the past 12 months, or;
• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Limitations and Caveats

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.

Results Point of Contact

• Title: Winfred Wang
• Organization: St Jude Children's Research Hospital

info@stjude.org

1-866-278-5833

Study Officials

• Ruth Williams, MS, RD, EdD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2005
• First Posted: August 18, 2005
• Study Start: May 1, 2004
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 26, 2017
• Results First Posted: May 12, 2010

Record last verified: 2010-03

Locations

US (1)