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

University College Dublin

Status: Completed

Conditions: Bone Health

Treatments: Dietary Supplement: Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D; Dietary Supplement: B-vitamin supplementation on bone health

Study type: Interventional

Funder types: Other

Identifiers

NCT03892395

UCD_456_2019

Details and patient eligibility

About

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.

Full 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)

Enrollment: 240 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: B-vitamin supplementation on bone health

Control group

Placebo Comparator group

Description:

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

Treatment:

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