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

• Sponsor: Hospital Authority, Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00563498
• Collaborator: The University of Hong Kong (Other), Fresienius Kabi HK Ltd (Other)
• Enrollment: 40
• Location: 1
• Duration (Months): 23
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Veno-Occlusive Disease; Hepatic Veno-Occlusive Disease; Mucositis	Drug: Glutamine	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Prevention
• 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 Start Date: Jul 1, 2004
• Anticipated Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. Veno-occlusive disease [1 month]

2. Mucositis [1 month]

Secondary Outcome Measures

1. Hospital stay [2 months]

2. Use of antibiotics [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary Hospital	Hong Kong		China

Sponsors and Collaborators

• Hospital Authority, Hong Kong
• 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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• HAREC Clinical Trial Registry

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00563498
• Other Study ID Numbers: EC1432-00; HARECCTR0500034
• First Posted: Nov 26, 2007
• Last Update Posted: Jul 7, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Veno-occlusive disease; Mucositis
• Additional relevant MeSH terms: Mucositis; Hepatic Veno-Occlusive Disease; Pulmonary Veno-Occlusive Disease

Study Results

No Results Posted as of Jul 7, 2010