Abstract

Abstract

Background: Vitamin B12 deficiency is common in older people and the prevalence increases with age. Vitamin B12 deficiency may present as macrocytic anaemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people. The diagnosis and indications for treatment are clear for individuals with low plasma levels of vitamin B12 in the setting of megaloblastic anaemia and neuropathy, but the relevance of treatment of vitamin B12 deficiency in the absence of such clinical signs is uncertain.

Methods: The aim of the present study is to assess whether dietary supplementation with crystalline vitamin B12 will improve electrophysiological indices of neurological function in older people who have biochemical evidence of vitamin B12 insufficiency in the absence of anaemia. To test this hypothesis we designed a randomized double-blind placebo-controlled trial involving 200 older people aged 75 years or greater who were randomly allocated to receive either a daily oral tablet containing 1 mg vitamin B12 or a matching placebo tablet. The primary outcome assessed at 12 months is change in electrophysiological indices of peripheral and central neurosensory responses required for mobility and sensory function. We here report the detailed study protocol.

Conclusions: In view of the high prevalence of vitamin B12 deficiency in later life, the present trial could have considerable significance for public health.

Details

Title
A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799]
Author
Dangour, Alan D; Allen, Elizabeth; Clarke, Robert; Elbourne, Diana; Fasey, Nicky; Fletcher, Astrid E; Letley, Louise; Richards, Marcus; Whyte, Ken; Mills, Kerry; Uauy, Ricardo
Pages
22
Publication year
2011
Publication date
2011
Publisher
BioMed Central
e-ISSN
14752891
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
902242399
Copyright
© 2011 Dangour et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.