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

July 6, 2010 updated by: Hospital Authority, Hong Kong

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Recruiting
        • Queen Mary Hospital
        • Sub-Investigator:
          • Raymond Liang, Prof
        • Sub-Investigator:
          • YH Leung, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Veno-occlusive disease
Time Frame: 1 month
1 month
Mucositis
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital stay
Time Frame: 2 months
2 months
Use of antibiotics
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Anticipated)

June 1, 2006

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 23, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC1432-00
  • HARECCTR0500034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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