Back to resultsEffects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients
Primary Purpose
Pulmonary Veno-Occlusive Disease, Hepatic Veno-Occlusive Disease, Mucositis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Glutamine
Sponsored by
About this trial
This is an interventional prevention trial for Pulmonary Veno-Occlusive Disease focused on measuring Veno-occlusive disease, Mucositis
Eligibility Criteria
Inclusion Criteria:
- Allogeneic bone marrow transplant recipients using busulfan and cyclophosphamide as conditioning.
Sites / Locations
- Queen Mary HospitalRecruiting
Outcomes
Primary Outcome Measures
Veno-occlusive disease
Mucositis
Secondary Outcome Measures
Hospital stay
Use of antibiotics
Full Information
NCT ID
NCT00563498
First Posted
November 21, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong, Fresienius Kabi HK Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00563498
Brief Title
Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients
Official Title
A Randomized Control Studies on the Effects of Glutamine on the Clinical Outcome of Bone Marrow Transplant Recipients With Special Reference to Veno-occlusive Disease and Mucositis.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
The University of Hong Kong, Fresienius Kabi HK Ltd
4. Oversight
5. Study Description
Brief Summary
The primary purpose of this project is to investigate if addition of glutamine, an amino acid, to standard parenteral nutrition, may improve the clinical outcome of the bone marrrow transplantation reducing the occurrence of veno-occlusive disease and severity of mucositis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Veno-Occlusive Disease, Hepatic Veno-Occlusive Disease, Mucositis
Keywords
Veno-occlusive disease, Mucositis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Glutamine
Primary Outcome Measure Information:
Title
Veno-occlusive disease
Time Frame
1 month
Title
Mucositis
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Hospital stay
Time Frame
2 months
Title
Use of antibiotics
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Allogeneic bone marrow transplant recipients using busulfan and cyclophosphamide as conditioning.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YH Leung, Dr
Phone
(852) 2855 3347
Email
ayhleung@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Lie, Dr
Organizational Affiliation
Department of Medicine/Division of Haematology, Queen Mary Hospital/ The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YH Leung, Dr
First Name & Middle Initial & Last Name & Degree
Raymond Liang, Prof
12. IPD Sharing Statement
Learn more about this trial
Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients
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