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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Stroke

Ischaemic

Diet and Nutrition

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]

Early Detection / Screening

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Serum levels of vitamin D.

Timepoint [1]

outcomes are assessed at 3 (primary timepoint) 6, 9, and 12 months post-enrolment

Primary outcome [2]

Serum levels of Highly sensitive C-reactive protein

Timepoint [2]

outcomes are assessed at 3 (primary timepoint) 6, 9, and 12 months post-enrolment

Primary outcome [3]

Serum levels of parathyroid hormone

Timepoint [3]

outcomes are assessed at 3 (primary timepoint) 6, 9, and 12 months post-enrolment

Secondary outcome [1]

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]

outcomes are assessed at 0, 6 and 12 months post-enrolment

Secondary outcome [2]

Number of injurious falls including severity of injuries (NDNQI® Injury Falls Measure)

Timepoint [2]

outcomes are assessed at 0, 6 and 12 months post-enrolment

Secondary outcome [3]

balance/gait status
outcome measure
• functional sit to stand performance (secs)
• step test score

Timepoint [3]

outcomes are assessed at 0, 6 and 12 months post-enrolment

Secondary outcome [4]

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]

outcomes are assessed at 0, 6 and 12 months post-enrolment

Secondary outcome [5]

existing levels of vitamin D supplementation in people with stroke through intitial recruitment interview

Timepoint [5]

At enrolment to study

Secondary outcome [6]

Serum levels of Highly sensitive C-reactive triglycerides

Timepoint [6]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [2]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [3]

Royal Melbourne Hospital - Royal Park campus - Parkville

Recruitment postcode(s) [1]

3065 - Fitzroy

Recruitment postcode(s) [2]

3050 - Parkville

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Perpetual Trustees (Samuel Nissen Foundation)

Address [1]

Level 18
Angel Place
123 Pitt Street
Sydney, New South Wales

Country [1]

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]

Hospital

Name [1]

St Vincents Hospital Melbourne

Address [1]

41 Victoria Parade
Fitzroy
Victoria 3065

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC)

Ethics committee address [1]

41 Victoria Parade
Fitzroy
Victoria 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

05/01/2018

Ethics approval number [1]

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

Dr Frances Batchelor

Address

NARI
PO Box 2127
Royal Melbourne Hospital
Victoria 3050

Country

Australia

Phone

+61 3 8387 2305

Fax

+61 3 9387 4030

F.Batchelor@nari.edu.au

Contact person for public queries

Name

Sue Williams

Address

NARI
PO Box 2127
Royal Melbourne Hospital
Victoria 3050

Country

Australia

Phone

+61 3 8387 2305

Fax

+61 3 9387 4030

s.williams@nari.edu.au

Contact person for scientific queries

Name

Frances Batchelor

Address

NARI
PO Box 2127
Royal Melbourne Hospital
Victoria 3050

Country

Australia

Phone

+61 3 8387 2305

Fax

+61 3 9387 4030

F.Batchelor@nari.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Biomarker Application for Precision Medicine in Stroke.	2020	https://dx.doi.org/10.1007/s12975-019-00762-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically