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

This study is currently recruiting participants.

Verified by University of Wisconsin, Madison, September 2005

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00204958

Purpose

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.

Condition	Intervention	Phase
Bone Marrow Transplantation Hematopoietic Stem Cell Transplantion	Drug: nutritional supplement Drug: glutamine popsicle	Phase IV

MedlinePlus related topics: Bone Marrow Transplantation Dietary Supplements

Drug Information available for: Glutamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Factorial Assignment
Official Title:	Evaluation of Glutamine Popsicles in Adult/Pediatric Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

grade of mucositis

Secondary Outcome Measures:

need for intravenous versus oral nutritional supplementation

Estimated Enrollment:	50
Study Start Date:	February 2004

Eligibility

Ages Eligible for Study:	4 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204958

Contacts

Contact: Gordon S Sacks, PharmD., FCCP, BCNSP

608-262-9491

gssacks@pharmacy.wisc.edu

Locations

United States, Wisconsin
University of Wisconsin	Recruiting
Madison, Wisconsin, United States, 53792
Contact: Gordon S Sacks, PharmD, FCCP, BCNSP 608-262-9491 gssacks@pharmacy.wisc.edu

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Gordon S Sacks, PharmD., FCCP, BCNSP

University of Wisconsin, Madison

More Information

Responsible Party:	University of Wisconsin ( Gordon S. Sacks, PharmD )
Study ID Numbers:	2003-222
Study First Received:	September 13, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00204958
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

bone marrow transplant (BMT)
hematopoietic stem cell transplant (HSCT)

ClinicalTrials.gov processed this record on January 16, 2009