MedDataX Logo

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

NCT ID: NCT03892395

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Health

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Healthy ageing B-vitamins Bone health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
2 year randomised, placebo controlled, double blinded intervention

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

B-vitamin supplementation on bone health

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

B-vitamin supplementation on bone health

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

Intervention Type DIETARY_SUPPLEMENT

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

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Ulster

OTHER

Sponsor Role collaborator

University College Dublin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lorraine Brennan

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lorraine Brennan, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University College Dublin

Dublin, Dublin 4, Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 36128889 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UCD_456_2019

Identifier Type: -

Identifier Source: org_study_id