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Trial registered on ANZCTR


Trial ID
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 289732 0
Level 11, 499 St Kilda Road
Melbourne, VIC 3004
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
Office for Research
Level 8, Harold Strokes Building
Austin Health
145 Studley Road
Heidelberg
Victoria
Australia 3084

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
Nutritional management of patients after spinal cord injury is complex and challenging. Dietitians currently estimate a patient’s nutritional requirements using standard equations of normal resting metabolism, adjusted for activity and stress levels. These equations have never been validated in the spinal cord injured population. To do this, metabolic activity will be measured using a technique called doubly labelled water. Patients are given a single dose of water labelled with a stable isotope. The elimination of the isotope over time directly measures metabolic activity.
Weight loss, commonly used to detect malnutrition, cannot distinguish between muscle wasting associated with paralysis and wasting from malnutrition. This study will therefore validate the use of an objective and non-invasive technique called bioelectrical impedance analysis (BIA) to measure segmental body composition (muscle, fat and water) in acute spinal cord injury. With segmental BIA, muscle wasting due to paralysis can be distinguished from wasting due to malnutrition. BIA measures will be validated by dual energy x-ray absorptiometry (DEXA), the gold standard for analysing body composition. BIA can be conducted at bedside and is therefore more clinically feasible and cost-effective for on-going assessment in this population where nutritional needs change through different phases of recovery.
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
m.galea@unimelb.edu.au
Contact person for public queries
Name 50527 0
Prof 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
m.galea@unimelb.edu.au
Contact person for scientific queries
Name 50528 0
Prof 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
m.galea@unimelb.edu.au