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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204958
First received: September 13, 2005
Last updated: September 29, 2015
Last verified: September 2015
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Evaluation of Glutamine Popsicles in Adult/Pediatric Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients

Resource links provided by NLM:

Drug Information available for: Glutamine
U.S. FDA Resources

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
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   4 Years to 75 Years   (Child, Adult, Senior)
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
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: NCT00204958

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
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, Madison
ClinicalTrials.gov Identifier: NCT00204958     History of Changes
Other Study ID Numbers: 2003-222 
Study First Received: September 13, 2005
Last Updated: September 29, 2015
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 September 26, 2016