Effects on Glutamine on the Outcome of Allogeneic Bone Ma... | NCT00563498

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

NCT00563498

Sponsor

Hospital Authority, Hong Kong

Status

Unknown status

Last Update Posted

Jul 7, 2010Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Pulmonary Veno-Occlusive Disease
Hepatic Veno-Occlusive Disease
Mucositis

Interventions

Glutamine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HARECCTR0500034

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Not provided

Completion Date

Jun 2006Estimated

First Submitted Date

Nov 21, 2007

First Submission Date that Met QC Criteria

Nov 23, 2007

First Posted Date

Nov 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2010

Last Update Posted Date

Jul 7, 2010Estimated

Name	Class
The University of Hong Kong	OTHER
Fresienius Kabi HK Ltd	UNKNOWN

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Glutamine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Veno-occlusive disease		1 month
Mucositis		1 month

Secondary Outcomes

Measure	Description	Time Frame
Hospital stay		2 months
Use of antibiotics		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YH Leung, Dr	Contact	(852) 2855 3347		ayhleung@hku.hk

Overall Officials

Name	Affiliation	Role
Albert Lie, Dr	Department of Medicine/Division of Haematology, Queen Mary Hospital/ The University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Mary Hospital	Recruiting	Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D011668	Pulmonary Veno-Occlusive Disease
D006504	Hepatic Veno-Occlusive Disease
D052016	Mucositis

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005973	Glutamine

Ancestor Terms

ID	Term
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000599	Amino Acids, Diamino

Browse Leaves

Not provided

Browse Branches

Not provided