Bone Health
Conditions
Keywords
Healthy ageing, B-vitamins, Bone health
Brief summary
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.
Detailed description
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)
Interventions
DIETARY_SUPPLEMENTB-vitamin supplementation on bone health
An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health
DIETARY_SUPPLEMENTControl group; Vitamin D, a daily capsule containing 10 µg/day vitamin D
Vitamin D, a daily capsule containing 10 µg/day vitamin D
Sponsors
University of Ulster
University College Dublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
2 year randomised, placebo controlled, double blinded intervention
Intervention model description
Supplementation for 2 years with one of the following treatments in capsule form: 1. Active: B vitamins + vitamin D, a daily capsule containing 200 µg/day folic acid, 10 µg/day vitamin B12, 10 mg/day vitamin B6 and 5 mg/day riboflavin, and 10 µg/day vitamin D combined. 2. Control/Placebo: Vitamin D, a daily capsule containing 10 µg/day vitamin D
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 50 years and over * Generally healthy, free living in the community * Males and females (post menopausal and not taking HRT)
Exclusion criteria
* Currently taking a supplement containing B vitamins * Currently consuming \>4 portions of foods fortified with B vitamins per week * Currently taking drugs known to interfere with folate/ B-vitamin metabolism * Have a condition of the gastrointestinal system (such as coeliac disease/ chron's disease, ulcerative colitis) or liver disease (hepatitis and NAFLD) * Be unable to consent to participate * Be currently involved in another research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of low dose B vitamins on bone mineral density | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolomics | 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 |
| Neurocognitive function II | 2 years | To determine the neurocognitive function using the Repeatable Battery for the Assessment of Neuropsychological Status 'RBANS' test (pre- and post-intervention) |
| Neurocognitive function I | 2 years | To determine the neurocognitive function using the Mini Mental State Exam 'MMSE' test (pre- and post-intervention) |
| Gut microbiome | 2 years | To collect faecal samples pre and post intervention to explore potential interactions with the gut microbiome |
| Blood pressure | 2 years | To measure blood pressure throughout the study and compare baseline to post intervention |
| Neurocognitive function III | 2 years | To determine the neurocognitive function using the Frontal Assessment Battery 'FAB' test (pre- and post-intervention) |
Countries
Ireland
Outcome results
None listed