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Trial registered on ANZCTR


Registration number
ACTRN12621000449831p
Ethics application status
Submitted, not yet approved
Date submitted
16/03/2021
Date registered
19/04/2021
Date last updated
19/04/2021
Date data sharing statement initially provided
19/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo-controlled trial on the effect of B12 skin patches on the wellbeing of residents living in aged care facilities
Scientific title
A randomised, double-blind, placebo-controlled trial on the effect of B12 skin patches on mood and falls risk in residents living in aged care facilities
Secondary ID [1] 303718 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional vitamin B12 deficiency 321143 0
Condition category
Condition code
Mental Health 318945 318945 0 0
Depression
Neurological 318946 318946 0 0
Other neurological disorders
Public Health 318947 318947 0 0
Health promotion/education
Metabolic and Endocrine 319273 319273 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin B12 skin patches. Weekly application to deltoid for 6 months.
1. Vitamin B12 “Energy on the Go” skin patches. Distributed by Patched Up Pty Ltd, Victoria, Australia. Non-toxic adhesive. Active ingredients: B12 (methylcobalamin) 1200ug; Folic acid 400ug.
2. Placebo patches distributed from Patched Up Pty Ltd, Victoria, Australia.
Other interventions: Blood tests to detect vitamin B12 and associated metabolites and for general health screening of these elderly participants
The patches will be applied by the employees at the nursing homes as per their drug administration policy and will be signed off on the medication chart.
Intervention code [1] 320027 0
Prevention
Comparator / control treatment
Placebo skin patches. Same patches but without the B12
Control group
Placebo

Outcomes
Primary outcome [1] 326872 0
The number of falls and near falls. This data will be collected from the residents' records and from incident reports. A comparison will be made between the number of falls and near falls in the intervention group and the number of falls and near falls in the placebo group.
Timepoint [1] 326872 0
6 months
Primary outcome [2] 327152 0
Blood serum metabolites MMA and homocysteine.
Timepoint [2] 327152 0
6 months
Primary outcome [3] 327153 0
Mood measured by the Profile of Mood States (POMS)
Timepoint [3] 327153 0
6 months
Secondary outcome [1] 392927 0
Energy measured by the vigour component of the POMS.
Timepoint [1] 392927 0
6 months
Secondary outcome [2] 393983 0
Symptoms of B12 deficiency measured using a Likert scale questionnaire
Timepoint [2] 393983 0
6 months

Eligibility
Key inclusion criteria
Inclusion criteria: ambulatory residents whose B12 and folate blood levels are within normal limits, with or without B12 oral supplements. Ambulatory is defined in this study as: walking independently, walking with the use of a walking aid or a single person standby assist.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: cognitively impaired (participants with an initial mini mental state examination (MMSE) score of 23 or less will be excluded from the study), severe chronic kidney disease or pernicious anaemia, and residents who are administered B12 injections or prescribed antidepressants.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Paired t tests and independent sample t tests (within and between group) data analyses will be performed using JASP or SPSS software. A Bayesian approach will be used. A power calculation carried out a priori using G*Power (Faul et al., 2007) indicated that a total sample size of 128 (64 participants in each group) would be adequate in order to have 80% power to detect differences between treatment groups of moderate effect size, and a total sample size of 54 participants would be adequate in order to have 95% power to detect differences within groups of moderate effect size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/07/2021
Actual
Date of last participant enrolment
Anticipated
30/09/2021
Actual
Date of last data collection
Anticipated
31/05/2022
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308128 0
Charities/Societies/Foundations
Name [1] 308128 0
WA Nurses Charitable Trust
Country [1] 308128 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive | Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 308886 0
None
Name [1] 308886 0
Address [1] 308886 0
Country [1] 308886 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308115 0
Edith Cowan University Research Ethics
Ethics committee address [1] 308115 0
270 Joondalup Drive | Joondalup WA 6027
Ethics committee country [1] 308115 0
Australia
Date submitted for ethics approval [1] 308115 0
28/01/2021
Approval date [1] 308115 0
Ethics approval number [1] 308115 0

Summary
Brief summary
Vitamin B12 is a water-soluble vitamin found in fish, eggs, meat and milk. An adequate level of B12 blood concentration is necessary to prevent anaemia, cognitive impairment and neuropathy.
B12 deficiency in older people is common. Symptoms include changes in mood and dizziness. It is important therefore that B12 deficiency is promptly treated, particularly in residents of aged care facilities who fall at a greater rate than the general population. Detection is complicated in cases of functional deficiency where B12 is within normal levels. Negative conditions of B12 deficiency can potentially be reversed by administering vitamin B supplements. Due to potential issues with the ageing gastrointestinal tract of the older adult, there is a requirement for an intervention using B12 supplements that bypass the gut. This study will investigate the effect of B12 supplementation in the form of skin patches on falls risk and mood in residents living in aged care facilities. As nurses are the primary clinicians involved in the reduction of falls in residents, demonstrating that falls risk in older people is impacted by the application of a non-prescription vitamin B12 patch could have major implications for nursing practice and public health policy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109586 0
Dr Sheila Mortimer-Jones
Address 109586 0
Edith Cowan University
270 Joondalup Drive | Joondalup WA 6027
Country 109586 0
Australia
Phone 109586 0
+61 8 6304 2528
Fax 109586 0
Email 109586 0
[email protected]
Contact person for public queries
Name 109587 0
Sheila Mortimer-Jones
Address 109587 0
Edith Cowan University
270 Joondalup Drive | Joondalup WA 6027
Country 109587 0
Australia
Phone 109587 0
+61 8 6304 2528
Fax 109587 0
Email 109587 0
[email protected]
Contact person for scientific queries
Name 109588 0
Sheila Mortimer-Jones
Address 109588 0
Edith Cowan University
270 Joondalup Drive | Joondalup WA 6027
Country 109588 0
Australia
Phone 109588 0
+61 8 6304 2528
Fax 109588 0
Email 109588 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data after de-identification, underlying published results only
When will data be available (start and end dates)?
Immediately following publication, ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Principal Investigator
Available for what types of analyses?
Any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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