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

NCT ID: NCT00204958

Last Updated: 2015-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Marrow Transplantation Hematopoietic Stem Cell Transplantion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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nutritional supplement

Intervention Type DRUG

glutamine popsicle

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gordon S Sacks, PharmD., FCCP, BCNSP

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2003-222

Identifier Type: -

Identifier Source: org_study_id

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