NCT03892395

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: University College Dublin · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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)

Conditions

• Bone Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	B-vitamin supplementation on bone health	An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health
DIETARY_SUPPLEMENT	Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D	Vitamin D, a daily capsule containing 10 µg/day vitamin D

Timeline

• Start date: 2017-05-05
• Primary completion: 2022-03-31
• Completion: 2022-05-31
• First posted: 2019-03-27
• Last updated: 2023-12-08

Locations

1 site across 1 country: Ireland