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NCT00563498 Clinical Trial

Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients

Mucositis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00563498
Other study ID # EC1432-00
Secondary ID HARECCTR0500034
Status Recruiting
Phase N/A
First received November 21, 2007
Last updated July 6, 2010
Start date July 2004
Est. completion date June 2006

Study information
Verified date July 2010
Source Hospital Authority, Hong Kong
Contact YH Leung, Dr
Phone (852) 2855 3347
Email ayhleung@hku.hk
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Allogeneic bone marrow transplant recipients using busulfan and cyclophosphamide as conditioning.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Glutamine

Locations
Country Name City State
China Queen Mary Hospital Hong Kong

Sponsors (3)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong Fresienius Kabi HK Ltd, The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Veno-occlusive disease 1 month
Primary Mucositis 1 month
Secondary Hospital stay 2 months
Secondary Use of antibiotics 2 months
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