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Trial registered on ANZCTR


Registration number
ACTRN12605000450617
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
20/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nocturnal nutritional supplementation in advanced liver disease - a randomised trial
Scientific title
A randomised trial of effects on total body protein status of nocturnal versus daytime nutritional supplementation in patients with liver cirrhosis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver cirrhosis 565 0
Condition category
Condition code
Other 640 640 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-centre, stratified, randomised study to compare total body protein changes in patients with liver cirrhosis taking a nutritional supplement (2 cans Ensure Plus or equivalent) either at night-time or daytime for 12 months.
Intervention code [1] 577 0
None
Comparator / control treatment
Daytime nutritional supplementation
Control group
Active

Outcomes
Primary outcome [1] 751 0
Total body protein change from baseline to 6 months.
Timepoint [1] 751 0
Measured at baseline and 6 months
Secondary outcome [1] 1540 0
Fatigue score
Timepoint [1] 1540 0
Measured at baseline, 3, 6 and 12 months.
Secondary outcome [2] 1541 0
Physiologic function
Timepoint [2] 1541 0
Measured at baseline, 3, 6 and 12 months.
Secondary outcome [3] 1542 0
Health-related quality of life
Timepoint [3] 1542 0
Measured at baseline, 3, 6 and 12 months.
Secondary outcome [4] 1543 0
GH/IGF axis
Timepoint [4] 1543 0
Measured at baseline, 3, 6 and 12 months.

Eligibility
Key inclusion criteria
Patients with chronic liver disease referred for nutritional support who have cirrhosis of the liver. Written informed consent.
Minimum age
16 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable or unwilling to take the food supplement as prescribed; on waiting list for liver transplantation.

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 sequence held by independent party with allocation to participants by sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated stratified blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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 outside Australia
Country [1] 222 0
New Zealand
State/province [1] 222 0

Funding & Sponsors
Funding source category [1] 701 0
Government body
Name [1] 701 0
Health Research Council of New Zealand
Address [1] 701 0
P.O. Box 5541, Wellesley Street, Auckland
Country [1] 701 0
New Zealand
Primary sponsor type
Individual
Name
Dr Lindsay Plank
Address
Department of Surgery, University of Auckland, P.B. 92019, Auckland
Country
New Zealand
Secondary sponsor category [1] 586 0
None
Name [1] 586 0
Nil
Address [1] 586 0
Country [1] 586 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35227 0
Address 35227 0
Country 35227 0
Phone 35227 0
Fax 35227 0
Email 35227 0
Contact person for public queries
Name 9766 0
Dr Lindsay Plank
Address 9766 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland
Country 9766 0
New Zealand
Phone 9766 0
+64 9 3074935
Fax 9766 0
+64 9 3779656
Email 9766 0
l.plank@auckland.ac.nz
Contact person for scientific queries
Name 694 0
Dr Lindsay Plank
Address 694 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland
Country 694 0
New Zealand
Phone 694 0
+64 9 3074935
Fax 694 0
+64 9 3779656
Email 694 0
l.plank@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary