Status:
TERMINATED
Trial of Oral Glutamine in Patients With Sickle Cell Anemia
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Anemia, Sickle Cell
Eligibility:
All Genders
5-18 years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00131508
Start Date
May 1 2004
End Date
April 1 2009
Last Update
April 26 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105