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Trial registered on ANZCTR


Registration number
ACTRN12618000358246
Ethics application status
Approved
Date submitted
2/02/2018
Date registered
9/03/2018
Date last updated
11/01/2019
Date data sharing statement initially provided
11/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin D and falls in people with stroke
Scientific title
The trajectory of Vitamin D and other biomarkers in older people in first 12 months after stroke and the relationship of these biomarkers with falls.
Secondary ID [1] 293721 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 306070 0
Condition category
Condition code
Injuries and Accidents 305207 305207 0 0
Other injuries and accidents
Stroke 305209 305209 0 0
Ischaemic
Diet and Nutrition 305210 305210 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The research program involves prospective observational study of vitamin D and other biochemical marker levels in the first twelve months after stroke, with falls, injury and physical function data also collected prospectively. The aims are to describe vitamin D and other biomarker levels in the first twelve months after stroke, To evaluate the associations between vitamin D, falls, injury and functional outcomes, including strength, balance and walking, and to determine existing levels of vitamin D supplementation in people with stroke.
Intervention code [1] 299975 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304670 0
Serum levels of vitamin D.
Timepoint [1] 304670 0
outcomes are assessed at 3 (primary timepoint) 6, 9, and 12 months post-enrolment
Primary outcome [2] 304671 0
Serum levels of Highly sensitive C-reactive protein
Timepoint [2] 304671 0
outcomes are assessed at 3 (primary timepoint) 6, 9, and 12 months post-enrolment
Primary outcome [3] 304893 0
Serum levels of parathyroid hormone
Timepoint [3] 304893 0
outcomes are assessed at 3 (primary timepoint) 6, 9, and 12 months post-enrolment
Secondary outcome [1] 342728 0
Number of fractures as a result of falls (including site and type of fracture)
Number of fractures will be assessed by the phsyiotherapist recording any fractures at the 0, 6, and 12 month assessment, and the researcher who conducts the monthly phone calls recording any change in health and service provision.
Timepoint [1] 342728 0
outcomes are assessed at 0, 6 and 12 months post-enrolment
Secondary outcome [2] 342729 0
Number of injurious falls including severity of injuries (NDNQI® Injury Falls Measure)
Timepoint [2] 342729 0
outcomes are assessed at 0, 6 and 12 months post-enrolment
Secondary outcome [3] 342730 0
balance/gait status
outcome measure
• functional sit to stand performance (secs)
• step test score
Timepoint [3] 342730 0
outcomes are assessed at 0, 6 and 12 months post-enrolment
Secondary outcome [4] 343550 0
Number of falls (as defined by “as an event which results in a person coming to rest inadvertently on the ground or floor or other lower level”). Falls prior to the initial assessment are assessed retrospectively by participant recall of falls in the previous 12 months. Falls in the observation period are collected prospectively by participants by recording any falls on a falls calendar, and confirmation of falls by researchers by monthly phones calls to participants.
Timepoint [4] 343550 0
outcomes are assessed at 0, 6 and 12 months post-enrolment
Secondary outcome [5] 343559 0
existing levels of vitamin D supplementation in people with stroke through intitial recruitment interview
Timepoint [5] 343559 0
At enrolment to study
Secondary outcome [6] 343560 0
Serum levels of Highly sensitive C-reactive triglycerides
Timepoint [6] 343560 0
outcomes are assessed at 0, 6 and 12 months post-enrolment

Eligibility
Key inclusion criteria
(1) aged at least 50 years, and for women post menopausal,
(2) admitted to hospital with first ever ischaemic stroke, confirmed by imaging preferably MRI (if MRI contraindicated, then evidence of stroke on CT),
(3) able to give informed consent or a person responsible providing informed consent,
(4) previously (prior to stroke) active and able to walk independently with/without aid in the community,
(5) previously (prior to stroke) residing in the community or a retirement village, and
(6) are likely to be discharged to non residential aged care accommodation on discharge from hospital.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded if they are
• Haemorrhagic stroke,
• receiving palliative care, and/or
• have kidney or liver conditions affecting vitamin D levels.
If female the participant can not be pre-menopausal.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample
A sample of fifty participants is required to provide a spread of participants with low vs normal vitamin D levels and a spread of people with/without supplementation at baseline. This is based on data from Batchelor (PhD Thesis, 2010) in which 15% of people returning home after stroke rehabilitation were already on vitamin D supplementation, and a further 25% for which vitamin D supplementation had been recommended, without establishment of vitamin D levels. While this study will not be fully powered to detect definitive differences in falls rates in relation to vitamin D, the sample size will be sufficient to detect a difference in Step Test performance between those with low vs normal vitamin D at final assessment (33% reduction in step test score in low vitamin D group – mean 8, sd=7, a = 0.05, power = 0.80).

Analysis
Data will be analysed by NARI research staff using quantitative methods. Descriptive statistics will be generated for all baseline data including vitamin D levels and other markers. Bivariate analysis will be used to identify differences in vitamin D/PTH/inflammatory markers between fallers and non-fallers and between those with no or one fall and those who have recurrent falls and between those with high vs low levels of physical function. Negative binomial regression will be used to determine difference in rate of falls between those with vitamin D deficiency and those without (significance p < 0.05).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/03/2018
Actual
19/04/2018
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
29/04/2020
Actual
Sample size
Target
50
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9946 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 9948 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 9949 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 18761 0
3050 - Parkville
Recruitment postcode(s) [2] 18759 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 298338 0
Charities/Societies/Foundations
Name [1] 298338 0
Perpetual Trustees (Samuel Nissen Foundation)
Country [1] 298338 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Ageing Research Institute
Address
PO Box 2127
Royal Melbourne Hospital
Victoria 3050
Country
Australia
Secondary sponsor category [1] 297453 0
Hospital
Name [1] 297453 0
St Vincents Hospital Melbourne
Address [1] 297453 0
41 Victoria Parade
Fitzroy
Victoria 3065
Country [1] 297453 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299329 0
St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 299329 0
41 Victoria Parade
Fitzroy
Victoria 3065
Ethics committee country [1] 299329 0
Australia
Date submitted for ethics approval [1] 299329 0
Approval date [1] 299329 0
05/01/2018
Ethics approval number [1] 299329 0
HREC Reference Number: HREC/17/SVHM/205 St Vincent’s HREC Ref: HREC 208/17

Summary
Brief summary
This project is a world first and vital step towards developing an effective falls prevention intervention for the large numbers of Australian stroke survivors. Fifty people aged over 50 years old with a diagnosis of first ever stroke will be recruited and monitored for 12 months for falls, falls injury, serum levels of vitamin D, parathyroid hormone, highly sensitive C-reactive protein and triglycerides, and strength, balance and walking in people after stroke. This project will produce detailed information and understanding about the link between vitamin D and falls in stroke survivors, an essential step in enabling the development and evaluation of effective falls prevention interventions (e.g. Vitamin D supplementation) for stroke survivors. The outcomes will enable clinicians and researchers to develop evidence-based interventions that will be implemented and tested in future projects in order to reduce falls and falls injury in older people after stroke and to improve their quality of life. The data produced by this project will mean that future phases of this work will attract government and other funding, such as National Health and Medical Research Funding. Overall impact will be measured by the development of a successful intervention that reduces falls in people with stroke.

Aims
1. Describe the trajectory of vitamin D levels in people in the first twelve months after stroke.
2. Describe the relationship between vitamin D levels, physical function (strength and balance), falls and injury in people in the twelve months after stroke.
3. Determine the relationship between other related biochemical markers (parathyroid hormone, C reactive protein and triglycerides) and falls in the twelve months after stroke.

Research Questions:
1. What is the trajectory of vitamin D levels in the first 12 months after stroke?
2. What is the current use of vitamin D supplementation in first 12 months after stroke?
3. Is vitamin D deficiency associated with physical function and falls in the twelve months following stroke?
4. Is vitamin D deficiency associated with injury severity following a fall in the twelve months after a
stroke?
5. What is the relationship between other biochemical markers (parathyroid hormone, highly sensitive C-reactive protein and triglycerides) and falls in stroke survivors in the first twelve months?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80078 0
Dr Frances Batchelor
Address 80078 0
NARI
PO Box 2127
Royal Melbourne Hospital
Victoria 3050
Country 80078 0
Australia
Phone 80078 0
+61 3 8387 2305
Fax 80078 0
+61 3 9387 4030
Email 80078 0
F.Batchelor@nari.edu.au
Contact person for public queries
Name 80079 0
Ms Sue Williams
Address 80079 0
NARI
PO Box 2127
Royal Melbourne Hospital
Victoria 3050
Country 80079 0
Australia
Phone 80079 0
+61 3 8387 2305
Fax 80079 0
+61 3 9387 4030
Email 80079 0
s.williams@nari.edu.au
Contact person for scientific queries
Name 80080 0
Dr Frances Batchelor
Address 80080 0
NARI
PO Box 2127
Royal Melbourne Hospital
Victoria 3050
Country 80080 0
Australia
Phone 80080 0
+61 3 8387 2305
Fax 80080 0
+61 3 9387 4030
Email 80080 0
F.Batchelor@nari.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Has not been discussed by project team. For discussion at next project meeting


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
EmbaseBiomarker Application for Precision Medicine in Stroke.2020https://dx.doi.org/10.1007/s12975-019-00762-3
N.B. These documents automatically identified may not have been verified by the study sponsor.