Vitamin K supplementation to reduce falls in older people - a multicentre trial
Vitamin K is involved in a wide range of biological processes, including vascular, bone, neurological and muscle function. Studies in osteoporosis suggest beneficial effects on bone mineral density, and pilot data suggest that vitamin K supplementation may be able to reduce postural sway in older people – a key risk factor for falls.
This pilot randomised controlled trial tested the optimum dose (200mcg and 400mcg vs placebo) of vitamin K given for one year to improve postural sway in a group of 96 older people at high risk of falls; tested recruitment rates for a large, community-based falls trial; and collected preliminary data on falls rates to inform the sample-size calculation for a full-scale trial. The economic analysis focused on the estimation of the worth of future additional research to reduce decision uncertainty, using pre-trial modelling, and calculated the optimal sample size for a future study.
Outcome and Translation
We found that costs were lower amongst participants in the low dose Vitamin K2 group, relative to high dose Vitamin K2 (£896-£902 versus £1033-£1044). Neither dose of vitamin K2 produced any improvement relative to placebo. The optimal sample size for a future trial would be 131 participants per group, and such a trial would remain cost-effective up to a sample size of 1100 per group.
The trial is regsitered with the ISRCTN registry: ISRCTN18436190
The project was discussed in a HERU Blog post - Vitamin K2 has no effect on reducing the risk of falls.
HERU researchers involved in this research project: Paul McNamee
External collaborators: M. Witham, M. McMurdo, P. Donnan, (Ninewells Hospital); R. Soiza (Applied Medicine, University of Aberdeen) and V. Cvoro (Department of Geriatric Medicine, Victoria Hospital).
Witham, M.D., Price, R.J.G., Band, M.M., Hannah, M.S., Fulton, R.L., Clarke, C.L., Donnan, P.T., McNamee, P., Cvoro, V. and Soiza, R.L. (2019) 'Effect of vitamin K2 on postural sway in older people who fall: a randomized controlled trial', Journal of the American Geriatrics Society, 67(10), 2102-2107.
Witham, M.D., Price, R.J.G., Band, M.M., Hannah, M.S., Fulton, R.L., Clarke, C.L., Donnan, P.T., McNamee, P., Cvoro, V. and Soiza, R.L. 'Effect of vitamin K2 on postural sway in older people who fall: a randomized controlled trial', British Geriatrics Society Spring Meeting 2019, Royal Welsh College of Music and Drama, Cardiff, Wales, 10-12 April 2019.