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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Effect of low dose B vitamins on bone mineral density
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
2 year randomised, placebo controlled, double blinded intervention
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50 years and over
- •Generally healthy, free living in the community
- •Males and females (post menopausal and not taking HRT)
排除标准
- •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
研究组 & 干预措施
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
干预措施: B-vitamin supplementation on bone health (Dietary Supplement)
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
干预措施: Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D (Dietary Supplement)
结局指标
主要结局
Effect of low dose B vitamins on bone mineral density
时间窗: 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
次要结局
- Metabolomics(2 years)
- Neurocognitive function III(2 years)
- Blood pressure(2 years)
- Neurocognitive function I(2 years)
- Neurocognitive function II(2 years)
- Gut microbiome(2 years)
研究者
Lorraine Brennan
Principle Investigator
University College Dublin