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

NCT03892395 | Completed

• 1 other identifier: UCD_456_2019
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Health

Keywords

Healthy ageing; B-vitamins; Bone health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Metabolomics

  2 years

• Neurocognitive function I

  2 years

• Neurocognitive function II

  2 years

• Neurocognitive function III

  2 years

• Gut microbiome

  2 years

Study Arms (2)

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

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

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

Interventions

B-vitamin supplementation on bone health DIETARY_SUPPLEMENT

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

Treatment group

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

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

Control group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over
• Generally healthy, free living in the community
• Males and females (post menopausal and not taking HRT)

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Dublin: lead
• University of Ulster: collaborator

Study Sites (1)

University College Dublin

Dublin, Dublin 4, D4, Ireland

Location

Related 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 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.

  PMID: 36128889 RESULT

MeSH Terms

Interventions

Control Groups; Vitamin D

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lorraine Brennan, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 2 year randomised, placebo controlled, double blinded intervention
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 27, 2019
• Study Start: May 5, 2017
• Primary Completion: March 31, 2022
• Study Completion: May 31, 2022
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)