Clinical trial NCT03892395: An Intervention Study to Investigate the Effect of B-vitamin Supplementation for 2-years on Bone Health
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Health
Keywords: Healthy ageing
B-vitamins
Bone health
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: University of Ulster
First posted: 2019-03-27
Enrollment: 240
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Supplementation for 2 years with one of the following treatments in capsule form:

1. 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.
2. Control/Placebo: Vitamin D, a daily capsule containing 10 µg/day vitamin D
Primary purpose: OTHER

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)

Eligibility criteria: 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

Primary outcomes:
measure: Effect of low dose B vitamins on bone mineral density
timeFrame: 2 years
Secondary outcomes:
measure: Metabolomics
timeFrame: 2 years
measure: Neurocognitive function I
timeFrame: 2 years
measure: Neurocognitive function II
timeFrame: 2 years
measure: Neurocognitive function III
timeFrame: 2 years
measure: Gut microbiome
timeFrame: 2 years
measure: Blood pressure
timeFrame: 2 years
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
state: Dublin 4
Study officials:
affiliation: University College Dublin
name: Lorraine Brennan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Supplementation Shows Benefits on Bone Mineral Density in Adults With Lower B12 Status. J Bone Miner Res. 2022 Dec;37(12):2443-2455. doi: 10.1002/jbmr.4709. Epub 2022 Oct 14.