Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000178549
Ethics application status
Approved
Date submitted
7/08/2014
Date registered
24/02/2015
Date last updated
14/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing nutritional status in patients with spinal cord injury
Scientific title
Using doubly labelled water, bioimpedance analysis and dual x-ray absorptiometry in people with spinal cord injury to evaluate energy requirements and body composition
Secondary ID [1] 285120 0
None
Universal Trial Number (UTN)
U1111-1160-1295
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury 292679 0
Condition category
Condition code
Neurological 292993 292993 0 0
Other neurological disorders
Injuries and Accidents 293234 293234 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants with recent spinal cord injury will be given a single dose of doubly labelled water (99% deuterium and 10% 18O) based on body weight (1.35gm per kg). Urine samples will be collected pre-dose and at regular intervals over a two week period post dose. Participants will also undergo bioimpedance analysis and dual x-ray absorptiometry.
Intervention code [1] 289971 0
Not applicable
Comparator / control treatment
Not applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292856 0
Energy expenditure measured by calculation of the elimination rates of deuterium and O-18 through the regular sampling of heavy isotope concentrations in the urine.
Timepoint [1] 292856 0
Urine samples taken on days 1, 2, 3, 4 and days 11, 12, 13, 14 post-dose of doubly labelled water (2-week period).
Secondary outcome [1] 309812 0
Body composition measured using dual x-ray absorptiometry (DEXA) and bioimpedance analysis (BIA).
Timepoint [1] 309812 0
Baseline only
Secondary outcome [2] 309813 0
Creatinine levels in urine
Timepoint [2] 309813 0
Samples taken at the beginning and end of the two week observation period.

Eligibility
Key inclusion criteria
Traumatic spinal cord injury less than 6 weeks previously
Surgical fixation of fracture
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ventilator dependent
Medically unstable

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Energy expenditure derived from mass spectrometry analysis of urine samples will be used to validate the Schofield Equation which is used clinically to estimate the basal metabolic rate and the total caloric intake required to maintain body mass. Fat mass and fat-free mass derived from the bioimpedance analysis will be correlated with the values obtained from dual x-ray absorptiometry (the current gold standard). The sample size of 20 participants is typical of that used to measure energy expenditure using doubly labelled water.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/12/2013
Actual
2/12/2013
Date of last participant enrolment
Anticipated
Actual
3/06/2016
Date of last data collection
Anticipated
Actual
18/06/2016
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2820 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 8507 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 289732 0
Charities/Societies/Foundations
Name [1] 289732 0
Institute for Safety Compensation and Recovery Research
Country [1] 289732 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville, VIC 3010
Country
Australia
Secondary sponsor category [1] 288425 0
None
Name [1] 288425 0
Address [1] 288425 0
Country [1] 288425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291467 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 291467 0
Ethics committee country [1] 291467 0
Australia
Date submitted for ethics approval [1] 291467 0
Approval date [1] 291467 0
09/08/2013
Ethics approval number [1] 291467 0
H2013 / 05117

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50526 0
Prof Mary Galea
Address 50526 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville, VIC 3010
Country 50526 0
Australia
Phone 50526 0
+61 3 8387 2017
Fax 50526 0
Email 50526 0
[email protected]
Contact person for public queries
Name 50527 0
Mary Galea
Address 50527 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville, VIC 3010
Country 50527 0
Australia
Phone 50527 0
+61 3 8387 2017
Fax 50527 0
Email 50527 0
[email protected]
Contact person for scientific queries
Name 50528 0
Mary Galea
Address 50528 0
Department of Medicine (Royal Melbourne Hospital)
The University of Melbourne
Parkville, VIC 3010
Country 50528 0
Australia
Phone 50528 0
+61 3 8387 2017
Fax 50528 0
Email 50528 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBedside quantification of fat-free mass in acute spinal cord injury using bioelectrical impedance analysis: A psychometric study.2018https://dx.doi.org/10.1038/s41393-017-0035-1
EmbaseComparison of segmental lean tissue mass in individuals with spinal cord injury measured by dual energy X-ray absorptiometry and predicted by bioimpedance spectroscopy.2021https://dx.doi.org/10.1038/s41393-020-00568-3
N.B. These documents automatically identified may not have been verified by the study sponsor.