NCT00204958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

3.2 years

First QC Date

September 13, 2005

Last Update Submit

September 29, 2015

Conditions

Bone Marrow TransplantationHematopoietic Stem Cell Transplantion

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • grade of mucositis

Secondary Outcomes (1)

  • need for intravenous versus oral nutritional supplementation

Interventions

nutritional supplementDRUG
glutamine popsicleDRUG

Eligibility Criteria

Age4 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males
  • Nonpregnant females
  • Receiving chemotherapy for BMT/HSCT

You may not qualify if:

  • Documented hepatic dysfunction
  • History of cirrhosis
  • History of acute renal failure (creatinine clearance \< 25 mL/min)
  • Gastrointestinal malabsorptive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Gordon S Sacks, PharmD., FCCP, BCNSP

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

February 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations

US(1)