An Intervention Study to Investigate the Effect of B-vitamin Supplementation for 2-years on Bone Health

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Bone Health

Intervention / Treatment
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* Dietary Supplement: B-vitamin supplementation on bone health
* Dietary Supplement: Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Supplementation for 2 years with one of the following treatments in capsule form: 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. Control/Placebo: Vitamin D, a daily capsule containing 10 µg/day vitamin D
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Supplementation for 2 years with one of the following treatments in capsule form: Treatment group will receive: 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 | Dietary Supplement: B-vitamin supplementation on bone health<br>* An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health<br>|
| Placebo Comparator: Control group<br>Supplementation for 2 years with one of the following treatments in capsule form: Control group will receive: Vitamin D, a daily capsule containing 10 µg/day vitamin D | Dietary Supplement: Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D<br>* Vitamin D, a daily capsule containing 10 µg/day vitamin D<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 
| Neurocognitive function I | To determine the neurocognitive function using the Mini Mental State Exam 'MMSE' test (pre- and post-intervention) | 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) | 2 years | 
| Neurocognitive function III | To determine the neurocognitive function using the Frontal Assessment Battery 'FAB' test (pre- and post-intervention) | 2 years | 
| Gut microbiome | To collect faecal samples pre and post intervention to explore potential interactions with the gut microbiome | 2 years | 
| Blood pressure | To measure blood pressure throughout the study and compare baseline to post intervention | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy ageing, B-vitamins, Bone health