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

Bone Health Clinical Trial

— Opti-Age  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03892395
• Other study ID #: UCD_456_2019
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: May 31, 2022

Study information

• Verified date: December 2023
• Source: University College Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Health

Intervention

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

Locations

Country	Name	City	State
Ireland	University College Dublin	Dublin	Dublin 4

Sponsors (2)

Lead Sponsor	Collaborator
University College Dublin	University of Ulster

Country where clinical trial is conducted

Ireland, 

References & Publications (1)

Clements M, Heffernan M, Ward M, Hoey L, Doherty LC, Hack Mendes R, Clarke MM, Hughes CF, Love I, Murphy S, McDermott E, Grehan J, McCann A, McAnena LB, Strain JJ, Brennan L, McNulty H. A 2-Year Randomized Controlled Trial With Low-Dose B-Vitamin Suppleme — View Citation

Outcome

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