University College Dublin
Dublin, Dublin 4, D4, Ireland
NCT Number: NCT03892395
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.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Dublin, Dublin 4, D4, Ireland
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)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 2 years
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 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
To determine the neurocognitive function using the Mini Mental State Exam 'MMSE' test (pre- and post-intervention)
Time frame: 2 years
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
To determine the neurocognitive function using the Frontal Assessment Battery 'FAB' test (pre- and post-intervention)
Time frame: 2 years
To collect faecal samples pre and post intervention to explore potential interactions with the gut microbiome
Time frame: 2 years
To measure blood pressure throughout the study and compare baseline to post intervention
University College Dublin
Other
A Randomised Controlled Trial to Investigate the Effect of Combined B-vitamin Supplementation for 2-years on Bone Mineral Density in Older Irish Adults With Sub-optimal B-vitamin Status
Acronym: Opti-Age
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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