Comparison of the Bioefficacy of Oral 25-hydroxyvitamin D3 and Vitamin D3 Supplements on Vitamin D Status in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- serum 25-hydroxyvitamin D concentration
研究概览
简要总结
The purpose of this study is to investigate whether a supplement of 25-hydroxyvitamin D is five-times more potent in raising vitamin D status (as reflected by serum 25(OH)D) compared to an equivalent amount of vitamin D3 in older adults. It will entail a 10 week supplementation study during winter months.
详细描述
The UK (McCance & Widdowson) food composition tables suggests that 25-hydroxyvitamin D (which is present in some foods, albeit at very low concentrations, but which is also commercially available) may possess up to 5-times the activity of native vitamin D3 in food. Thus, in theory, each micogram of 25-hydroxyvitamin D consumed in the diet could boost vitamin D status up to five times most effectively compared to each microgram of native vitamin D in food. It is worth noting, however, that estimates of potency range from 2 to 5, depending on approach used, and that the real potency needs to be confirmed in a human study. This study aims to examine the biological activity of 25-hydroxyvitamin D (i.e., its potency relative to vitamin D3) as well as its effect on selected functional markers in a randomised, double-blind, human intervention trial in older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be eligible if they are 45+ years of age
- •Body Mass Index (BMI) 19-30
排除标准
- •have hypercalcaemia
- •chronic illness
- •renal or liver disorders
- •taking medications that might interact with vitamin D or metabolite
- •drank more than > 21 standards (male)/ 14 standards (female) of alcohol per week
- •planning to change smoking habits
结局指标
主要结局
serum 25-hydroxyvitamin D concentration
时间窗: 10 weeks
次要结局
- serum parathyroid hormone(10 weeks)
- blood pressure(10 weeks)
- biochemical markers of bone turnover(10 weeks)
- serum calcium adjusted for albumin(10 weeks)
研究者
Kevin D. Cashman
Professor of Food and Health
University College Cork