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NCT00204958 Clinical Trial

Glutamine Popsicles in Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients

Bone Marrow Transplantation Clinical Trial

Official title:
Evaluation of Glutamine Popsicles in Adult/Pediatric Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00204958
Other study ID # 2003-222
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated September 29, 2015
Start date February 2004
Est. completion date May 2007

Study information
Verified date September 2015
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Nutrition is an important part of the recovery process after having a head injury so that subjects can gain strength and fight off infection. Liquid nutrition formulas are often given to patients through a tube that has been placed into the intestines for feeding when they are unable to eat on their own. Some reports suggest that nutrition with extra amounts of the amino acid called glutamine may decrease infections and hospital stay in severely injured patients. The purpose of this study is to evaluate if giving extra amounts of an amino acid called glutamine with liquid nutrition formulas will decrease the risk of infection and length of stay in the intensive care unit after having a head injury.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 75 Years
Eligibility Inclusion Criteria:

- Males

- Nonpregnant females

- Receiving chemotherapy for BMT/HSCT

Exclusion Criteria:

- Documented hepatic dysfunction

- History of cirrhosis

- History of acute renal failure (creatinine clearance < 25 mL/min)

- Gastrointestinal malabsorptive disorder

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• nutritional supplement

• glutamine popsicle

Locations
Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary grade of mucositis
Secondary need for intravenous versus oral nutritional supplementation
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