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Trial registered on ANZCTR
Registration number
ACTRN12624000792527
Ethics application status
Approved
Date submitted
8/06/2024
Date registered
27/06/2024
Date last updated
27/06/2024
Date data sharing statement initially provided
27/06/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Improving the microbiome with prebiotics during cancer treatment- acute leukemia
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Scientific title
Feasibility of prebiotic fibre supplementation during treatment for acute leukemia, a pilot randomised control trial in patients with newly diagnosed acute leukemia
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Secondary ID [1]
312304
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nil
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Universal Trial Number (UTN)
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Trial acronym
IMPaCT Leukemia
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
haematological cancer
334048
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acute leukemia
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Condition category
Condition code
Blood
330719
330719
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0
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Haematological diseases
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Cancer
330720
330720
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0
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Leukaemia - Acute leukaemia
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Diet and Nutrition
330721
330721
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0
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This trial evaluates feasibility of an oral prebiotic fibre supplement during treatment for acute leukemia and the impact on clinical outcomes, the microbiome and immune function. The trial will take place on the haematology unit at the Royal Brisbane and Women's Hospital. The trial compares oral prebiotic supplementation (group 1) to standard care (group 2).
Group 1 will commence an oral prebiotic fibre supplement from the start of induction treatment after diagnosis and continue until the end of consolidation chemotherapy. The supplement will be provided for 3-6 months depending on number of consolidation cycles required. The prebiotic is a powdered fibre supplement mix of inulin, resistant starch and psyllium, split into two doses. Two sachets per day will provide a combined dose of 22g fibre per day. Participants will be advised to take the supplement with a meal and to commence 1 sachet per day for the first 3 days then increase to 2 sachets per day. Adherence will be measured by patients reporting consumption fortnightly (number of sachets provided compared to number remaining each fortnight and whether full sachets were consumed).
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Intervention code [1]
328777
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Treatment: Other
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Comparator / control treatment
Group 2 will receive standard care with no fibre supplementation. There will be no difference in nutrition care or medical treatment between groups.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility of prebiotic fibre supplementation, defined as patients consuming >80% of the prescribed supplement over the study period.
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Assessment method [1]
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Patient report of number of sachets consumed compared to number provided fortnightly. This is collected in person during inpatient treatment and by a REDCap emailed questionnaire when an outpatient (specifically designed for this study).
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Timepoint [1]
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Every week during induction treatment then every two weeks during the remaining supplementation period.
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Secondary outcome [1]
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Patient acceptability of the oral prebiotic supplement
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Assessment method [1]
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A questionnaire developed specifically for the study sent from REDCap.
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Timepoint [1]
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At the end of induction treatment and at the end of second consolidation treatment.
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Secondary outcome [2]
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Incidence of infections
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Assessment method [2]
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Common Terminology Criteria for Adverse Events (CTCAE) > grade 2 grading from medical chart
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Timepoint [2]
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Collected continuously from study commencement to the end of the supplementation period.
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Secondary outcome [3]
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Length of hospital stay (days)
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Assessment method [3]
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medical chart
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Timepoint [3]
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At hospital discharge after induction treatment.
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Secondary outcome [4]
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Unplanned hospital admissions
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Assessment method [4]
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medical chart
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Timepoint [4]
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At the end of second consolidation treatment
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Secondary outcome [5]
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Disease relapse
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Assessment method [5]
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medical chart
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Timepoint [5]
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End of study (end of acute leukemia treatment for each patient, either end of consolidation treatment or post stem cell transplantation)
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Secondary outcome [6]
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Nutritional status
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Assessment method [6]
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Subjective global assessment tool
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Timepoint [6]
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Baseline, end of induction treatment and end of second consolidation treatment.
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Secondary outcome [7]
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Dietary intake
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Assessment method [7]
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Assessed using the validated CNAQ tool (comprehensive nutrition assessment questionnaire) at baseline as well as patients self reporting intake via a food diary for three consecutive days at timepoints below.
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Timepoint [7]
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At baseline, end of induction treatment, end of second consolidation treatment, and end of all consolidation (for patients having more than 2 cycles).
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Secondary outcome [8]
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Gastrointestinal symptoms
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Assessment method [8]
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CTCAE and PRO-CTCAE
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Timepoint [8]
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Baseline, weekly during induction treatment and end of second consolidation treatment,
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Secondary outcome [9]
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Quality of life
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Assessment method [9]
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The European Organisation for Research and Treatment of Cancer, quality of life questionnaire (EORTC QLQ-C30)
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Timepoint [9]
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Baseline, end of induction treatment, end of second consolidation treatment.
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Secondary outcome [10]
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Survival
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Assessment method [10]
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medical chart
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Timepoint [10]
436095
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End of induction treatment, end of second consolidation and end of treatment for acute leukemia.
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Eligibility
Key inclusion criteria
• age 18 years or older
• newly diagnosed acute leukemia or myelodysplasia undergoing high intensity
intravenous induction chemotherapy at the Royal Brisbane and Women’s Hospital
(RBWH)
• ability to provide written informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• inflammatory bowel disease
• formal diagnosis of irritable bowel syndrome
• gastrointestinal resection
• ileostomy or colostomy
• any bariatric surgery including gastric bypass surgery, sleeve gastrectomy and gastric
band
• a contraindication to a high fibre diet (e.g. active diverticulitis or bowel obstruction)
• allergy/ intolerance to any ingredient in the fibre supplement
• current and planned ongoing consumption of probiotic or prebiotic supplement
• hepatitis B, hepatitis C or HIV infection unless viral load negative
• on carbamazepine
• inability to provide written informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The investigator recruiting participants will be unable to see which group they will be allocated to until after recruitment when the randomisation will be completed in REDCap. In REDCap future allocations are concealed.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to study commencement, a randomisation table created by computer software will be entered into the REDCap database by an investigator not involved in recruitment.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/08/2024
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Actual
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Date of last participant enrolment
Anticipated
30/03/2026
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
316696
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Other
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Name [1]
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Gateway for Cancer Research
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Address [1]
316696
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Country [1]
316696
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United States of America
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Primary sponsor type
Hospital
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Name
Metro North Hospital and Health Service
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Address
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Country
Australia
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Secondary sponsor category [1]
318897
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None
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Name [1]
318897
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Address [1]
318897
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Country [1]
318897
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315476
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Metro North Health Human Research Ethics Committee B
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Ethics committee address [1]
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https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
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Ethics committee country [1]
315476
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Australia
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Date submitted for ethics approval [1]
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26/02/2024
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Approval date [1]
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22/04/2024
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Ethics approval number [1]
315476
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Summary
Brief summary
This pilot study is evaluating the feasibility of providing an oral prebiotic fibre supplement during treatment for acute leukemia. It will assess tolerance and whether prebiotic supplementation can improve the microbiome and reduce complications. Patients may be eligible to join this study if they are aged 18 years and older undergoing treatment for acute leukemia at the Royal Brisbane and Women’s Hospital (RBWH). Participants in this study will be randomly allocated to the intervention group or the control group. Participants allocated to the intervention will receive an oral prebiotic fibre supplement from the start of induction treatment until the end of their consolidation treatment. The control group will receive usual care. It is hoped that prebiotic supplementation will support the microbiome and improve health outcomes for participants undergoing acute leukemia treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Sarah Andersen
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Address
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Dietetics and Foodservices, Level 2, Dr James Mayne Building, Royal Brisbane and Womens Hospital, Butterfield St, Herston, QLD, 4029
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Country
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Australia
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Phone
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+61 7 36468268
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Sarah Andersen
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Address
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Dietetics and Foodservices, Level 2, Dr James Mayne Building, Royal Brisbane and Womens Hospital, Butterfield St, Herston, QLD, 4029
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Country
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Australia
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Phone
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+61 7 36468268
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Sarah Andersen
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Address
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Dietetics and Foodservices, Level 2, Dr James Mayne Building, Royal Brisbane and Womens Hospital, Butterfield St, Herston, QLD, 4029
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Country
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Australia
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Phone
134812
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+61 7 36468268
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Fax
134812
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Email
134812
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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