Bone HealthOpti-AgeNCT03892395
An Intervention Study to Investigate the Effect of B-vitamin Supplementation for 2-years on Bone Health
A study testing B-vitamin supplementation on bone health in people with Bone Health, run by University College Dublin at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Health
- What is being tested?
- B-vitamin supplementation on bone health
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteIreland
- Study dates
- 5 May 2017to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years and over
- Generally healthy, free living in the community
- Males and females (post menopausal and not taking HRT)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- B-vitamin supplementation on bone health, Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D
- Keywords
- Healthy ageing, B-vitamins, Bone health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-vitamin supplementation on bone healthDietary 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 DDietary supplement
Vitamin D, a daily capsule containing 10 µg/day vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | 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 Receives: Dietary Supplement: B-vitamin supplementation on bone health |
| Control group | Placebo comparator | 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 Receives: Dietary Supplement: Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (6)
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
Measured: 2 years
Neurocognitive function I
To determine the neurocognitive function using the Mini Mental State Exam 'MMSE' test (pre- and post-intervention)
Measured: 2 years
Neurocognitive function II
To determine the neurocognitive function using the Repeatable Battery for the Assessment of Neuropsychological Status 'RBANS' test (pre- and post-intervention)
Measured: 2 years
Neurocognitive function III
To determine the neurocognitive function using the Frontal Assessment Battery 'FAB' test (pre- and post-intervention)
Measured: 2 years
Gut microbiome
To collect faecal samples pre and post intervention to explore potential interactions with the gut microbiome
Measured: 2 years
Blood pressure
To measure blood pressure throughout the study and compare baseline to post intervention
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start5 May 2017
- Primary completion31 Mar 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster
- Responsible party
- Principal investigator, Lorraine Brennan, University College Dublin
- Investigators
- Lorraine Brennan, PhD, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892395
- Sponsor's protocol ID
- UCD_456_2019
- Acronym
- Opti-Age
- Status last verified
- Dec 2023
- First submitted
- 22 Mar 2019
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36128889
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03892395
- Acronym / sponsor ID
- Opti-Age / UCD_456_2019
- Conditions
- Bone Health
- Keywords
- Healthy ageing, B-vitamins, Bone health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- University of Ulster
- Study start
- 5 May 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Dietary Supplement: B-vitamin supplementation on bone healthSupplementation 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 |
| Control group | Placebo comparator | Dietary Supplement: Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin DSupplementation 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50 years and over
- Generally healthy, free living in the community
- Males and females (post menopausal and not taking HRT)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-vitamin supplementation on bone healthAn intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health | Dietary supplement | Treatment group |
| Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin DVitamin D, a daily capsule containing 10 µg/day vitamin D | Dietary supplement | Control group |
Primary outcome
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
6 secondary outcomes
Metabolomics
Time frame: 2 years
Neurocognitive function I
Time frame: 2 years
Neurocognitive function II
Time frame: 2 years
Neurocognitive function III
Time frame: 2 years
Gut microbiome
Time frame: 2 years
Blood pressure
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Results publication: PubMed 36128889Clements 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorraine Brennan, PhD principal investigator
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-vitamin supplementation on bone health in people with Bone Health, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of low dose B vitamins on bone mineral density (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03892395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.