NCT00563498

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

First QC Date

November 21, 2007

Last Update Submit

July 6, 2010

Conditions

Pulmonary Veno-Occlusive DiseaseHepatic Veno-Occlusive DiseaseMucositis

Keywords

Veno-occlusive diseaseMucositis

Outcome Measures

Primary Outcomes (2)

  • Veno-occlusive disease

    1 month

  • Mucositis

    1 month

Secondary Outcomes (2)

  • Hospital stay

    2 months

  • Use of antibiotics

    2 months

Interventions

GlutamineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Veno-Occlusive DiseaseHepatic Veno-Occlusive DiseaseMucositis

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesVascular DiseasesCardiovascular DiseasesLiver DiseasesDigestive System DiseasesGastroenteritisGastrointestinal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Neutral

Study Officials

  • Albert Lie, Dr

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

YH Leung, Dr

CONTACT

(852) 2855 3347ayhleung@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

July 1, 2004

Study Completion

June 1, 2006

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

CN(1)