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

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ClinicalTrials.gov Identifier: NCT00204958
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Bone Marrow Transplantation Hematopoietic Stem Cell Transplantion Drug: nutritional supplement Drug: glutamine popsicle Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Evaluation of Glutamine Popsicles in Adult/Pediatric Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients
Study Start Date : February 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. grade of mucositis

Secondary Outcome Measures :
  1. need for intravenous versus oral nutritional supplementation

Eligibility Criteria
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Ages Eligible for Study:   4 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00204958     History of Changes
Other Study ID Numbers: 2003-222
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

Keywords provided by University of Wisconsin, Madison:
bone marrow transplant (BMT)
hematopoietic stem cell transplant (HSCT)