An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health. This is a dual centre (UCD and University of Ulster) 2-year randomised, placebo controlled, double blind intervention.
Osteoporosis is a major public health issue, especially among older adults. The condition is widespread, with an estimated 1 in 2 women and 1 in 5 men over the age of 50 years expected to have an osteoporotic fracture. The associated health care costs are considerable and growing as the population of older adults increases. Furthermore, osteoporotic fractures are associated with loss of independence and risk of further fractures and health problems for the individual. Given these negative impacts, new approaches to help maintain better bone health in older age are urgently needed. Vitamin D and calcium have well established protective roles, however, other evidence links certain B vitamins with bone health. This study will investigate the effect of B-vitamin supplementation over a two year period at two centres (UCD and University of Ulster)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
240
An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health
Vitamin D, a daily capsule containing 10 µg/day vitamin D
University College Dublin
Dublin, Dublin 4, Ireland
Effect of low dose B vitamins on bone mineral density
A 2 year Randomized Control Trial (RCT) to investigate the effect of low dose B vitamins on bone mineral density (as measured by dual energy X-ray absorptiometry- DXA) in older Irish adults with sub-optimal B-vitamin status at baseline. A DXA bone scan will be performed pre and post the 2-year intervention to evaluate beneficial effects to bone mineral density
Time frame: 2 years
Metabolomics
Metabolomics analysis of blood samples collected pre and post the trial to explore the mechanistic effects of B- vitamins on bone and other outcomes
Time frame: 2 years
Neurocognitive function I
To determine the neurocognitive function using the Mini Mental State Exam 'MMSE' test (pre- and post-intervention)
Time frame: 2 years
Neurocognitive function II
To determine the neurocognitive function using the Repeatable Battery for the Assessment of Neuropsychological Status 'RBANS' test (pre- and post-intervention)
Time frame: 2 years
Neurocognitive function III
To determine the neurocognitive function using the Frontal Assessment Battery 'FAB' test (pre- and post-intervention)
Time frame: 2 years
Gut microbiome
To collect faecal samples pre and post intervention to explore potential interactions with the gut microbiome
Time frame: 2 years
Blood pressure
To measure blood pressure throughout the study and compare baseline to post intervention
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Time frame: 2 years