- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00204958
Glutamine Popsicles in Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients
September 29, 2015 updated by: University of Wisconsin, Madison
Evaluation of Glutamine Popsicles in Adult/Pediatric Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
grade of mucositis
|
Secondary Outcome Measures
Outcome Measure |
---|
need for intravenous versus oral nutritional supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gordon S Sacks, PharmD., FCCP, BCNSP, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
May 1, 2007
Study Completion (Actual)
May 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
October 1, 2015
Last Update Submitted That Met QC Criteria
September 29, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 2003-222
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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