Effects on Glutamine on the Outcome of Allogeneic Bone Marrow Transplant Recipients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 21, 2007

Last Updated Date

December 15, 2008

Start Date ^†

July 2004

Current Primary Outcome Measures ^†

Veno-occlusive disease [ Time Frame: 1 month ]
Mucositis [ Time Frame: 1 month ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00563498 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Hospital stay [ Time Frame: 2 months ]
Use of antibiotics [ Time Frame: 2 months ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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.

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.

Detailed Description

Study Phase

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Pulmonary Veno-Occlusive Disease
Hepatic Veno-Occlusive Disease
Mucositis

Intervention ^†

Drug: Glutamine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

June 2006

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: YH Leung, Dr

(852) 2855 3347

ayhleung@hku.hk

Location Countries ^†

China

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00563498

Responsible Party

Secondary IDs ^††

HARECCTR0500034

Study Sponsor ^†

Hospital Authority, Hong Kong

Collaborators ^††

The University of Hong Kong
Fresienius Kabi HK Ltd

Investigators ^†

Principal Investigator:

Albert Lie, Dr

Department of Medicine/Division of Haematology, Queen Mary Hospital/ The University of Hong Kong

Information Provided By

Hospital Authority, Hong Kong

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.