|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00204958 |
|
Date of registration:
|
13/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Glutamine Popsicles in Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients
|
|
Scientific title:
|
Evaluation of Glutamine Popsicles in Adult/Pediatric Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT) Patients |
|
Date of first enrolment:
|
February 2004 |
|
Target sample size:
|
50 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00204958 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Gordon S Sacks, PharmD, FCCP, BCNSP |
|
Address:
|
|
|
Telephone:
|
608-262-9491 |
|
Email:
|
gssacks@pharmacy.wisc.edu |
|
Affiliation:
|
|
|
|
Name:
|
Gordon S Sacks, PharmD., FCCP, BCNSP |
|
Address:
|
|
|
Telephone:
|
608-262-9491 |
|
Email:
|
gssacks@pharmacy.wisc.edu |
|
Affiliation:
|
|
|
|
Name:
|
Gordon S Sacks, PharmD., FCCP, BCNSP |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Wisconsin, Madison |
|
|
Key inclusion & exclusion 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
Age minimum:
4 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Bone Marrow Transplantation
|
|
Hematopoietic Stem Cell Transplantion
|
|
Intervention(s)
|
|
Drug: glutamine popsicle
|
|
Drug: nutritional supplement
|
|
Primary Outcome(s)
|
|
grade of mucositis
|
|
Secondary Outcome(s)
|
|
need for intravenous versus oral nutritional supplementation
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|