Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000436077
Ethics application status
Approved
Date submitted
26/05/2010
Date registered
28/05/2010
Date last updated
28/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of oral nutritional supplementation for older women after a fracture
Scientific title
Effectiveness of oral nutritional supplementation for older women after a fracture on nutritional status and functioning
Secondary ID [1] 251873 0
None
Universal Trial Number (UTN)
Trial acronym
EONS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Undernutrition 257467 0
Condition category
Condition code
Diet and Nutrition 257617 257617 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One pack of high protein, high calorie oral nutritional supplement (Sustagen Hospital Plus (235mls), or Novasource 2.0 (237mls)) daily for 40 days.
Intervention code [1] 256557 0
Treatment: Other
Comparator / control treatment
Usual care in hospital for as long as indicated due to the fracture, and then usual healthcare at home for the duration of the study. Usual care will vary on a case by case basis.
Control group
Active

Outcomes
Primary outcome [1] 258527 0
Weight, as measured by spring scales.
Timepoint [1] 258527 0
40 days and 4 months after randomisation
Secondary outcome [1] 264360 0
Gait velocity, as measured over 2.4 metres by a stopwatch
Timepoint [1] 264360 0
40 days and 4 months after randomisation

Eligibility
Key inclusion criteria
Moderate or severe protein energy malnutrition
Minimum age
70 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Metastatic cancer, chronic renal failure or hepatic failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was recorded on a card sealed in a sequentially numbered opaque envelope. Once informed consent was given, the research nurse opened the next numbered envelope and informed the participant of the group to which they had been randomized.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence was derived from a random numbers table. Randomization was stratified for hip or other fracture, and extent of undernutrition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257053 0
Hospital
Name [1] 257053 0
Hornsby Ku-ring-gai Hospital
Country [1] 257053 0
Australia
Primary sponsor type
Hospital
Name
Hornsby Ku-ring-gai Hospital
Address
Palmerston Rd
Hornsby NSW 2077
Country
Australia
Secondary sponsor category [1] 256313 0
Individual
Name [1] 256313 0
Ian Cameron
Address [1] 256313 0
Rehabilitation Studies Unit
PO Box 6
Ryde NSW 1680
Country [1] 256313 0
Algeria

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259080 0
Hornsby Ku-ring-gai Hospital
Ethics committee address [1] 259080 0
Palmerston Road
Hornsby NSW 2077
Ethics committee country [1] 259080 0
Australia
Date submitted for ethics approval [1] 259080 0
Approval date [1] 259080 0
01/12/1999
Ethics approval number [1] 259080 0
Not available

Summary
Brief summary
The study investigated the effectiveness of a high calorie, high protein nutritional supplement in terms of changes in recovery rate as measured by abilities in activities of daily living (ADL), and nutritional status.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31226 0
Address 31226 0
Country 31226 0
Phone 31226 0
Fax 31226 0
Email 31226 0
Contact person for public queries
Name 14473 0
Ian Cameron
Address 14473 0
Rehabilitation Studies Unit
PO Box 6
Ryde NSW 1680
Country 14473 0
Australia
Phone 14473 0
+61 298089236
Fax 14473 0
+61 298099037
Email 14473 0
[email protected]
Contact person for scientific queries
Name 5401 0
Ian Cameron
Address 5401 0
Rehabilitation Studies Unit
PO Box 6
Ryde NSW 1680
Country 5401 0
Australia
Phone 5401 0
+61 298089236
Fax 5401 0
+61 298099037
Email 5401 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
No additional documents have been identified.