Skip to main content
OpenTrials
Completed

NCT Number: NCT03892395

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Dublin, Dublin 4, D4, Ireland

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

B-vitamin supplementation on bone health

Dietary Supplement

An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health

Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D

Dietary Supplement

Vitamin D, a daily capsule containing 10 µg/day vitamin D

Primary outcomes

  1. Effect of low dose B vitamins on bone mineral density

    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

Secondary outcomes

  1. Metabolomics

    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

  2. Neurocognitive function I

    Time frame: 2 years

    To determine the neurocognitive function using the Mini Mental State Exam 'MMSE' test (pre- and post-intervention)

  3. Neurocognitive function II

    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)

  4. Neurocognitive function III

    Time frame: 2 years

    To determine the neurocognitive function using the Frontal Assessment Battery 'FAB' test (pre- and post-intervention)

  5. Gut microbiome

    Time frame: 2 years

    To collect faecal samples pre and post intervention to explore potential interactions with the gut microbiome

  6. Blood pressure

    Time frame: 2 years

    To measure blood pressure throughout the study and compare baseline to post intervention

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

  • University of Ulster

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 27, 2019
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

Published trials that share one or more normalized conditions with this study.