An Intervention Study to Investigate the Effect of B-vitamin Supplementation for 2-years on Bone Health (Opti-Age)
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 Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dublin 4
-
Dublin, Dublin 4, Ireland, D4
- University College Dublin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment group
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 |
An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health
|
|
Placebo Comparator: Control group
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 |
Vitamin D, a daily capsule containing 10 µg/day vitamin D
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 years
|
|
Neurocognitive function I
Time Frame: 2 years
|
To determine the neurocognitive function using the Mini Mental State Exam 'MMSE' test (pre- and post-intervention)
|
2 years
|
|
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)
|
2 years
|
|
Neurocognitive function III
Time Frame: 2 years
|
To determine the neurocognitive function using the Frontal Assessment Battery 'FAB' test (pre- and post-intervention)
|
2 years
|
|
Gut microbiome
Time Frame: 2 years
|
To collect faecal samples pre and post intervention to explore potential interactions with the gut microbiome
|
2 years
|
|
Blood pressure
Time Frame: 2 years
|
To measure blood pressure throughout the study and compare baseline to post intervention
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lorraine Brennan, PhD, University College Dublin
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCD_456_2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.