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A randomised, double-blind, placebo-controlled trial on the effect of B12 skin patches on the wellbeing of residents living in aged care facilities

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000449831
Enrollment
200
Registered
2021-04-19
Start date
2021-07-05
Completion date
2021-09-30
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Edith Cowan University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026