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

Not Applicable

Completed

• Conditions: Bone Health
• Interventions: Dietary Supplement: B-vitamin supplementation on bone health; Dietary Supplement: Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D

• Registration Number: NCT03892395
• Lead Sponsor: University College Dublin

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)

Study Timeline

• Study Start: 2017-05-05
• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-27
• Primary Completion: 2022-03-31
• Study Completion: 2022-05-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	B-vitamin supplementation on bone health	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
Control group	Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University College Dublin; 🇮🇪 Dublin, Dublin 4, Ireland