A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status: a Randomised Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Total 25-hydroxyvitamin D concentration
研究概览
简要总结
The aim of the study is to compare the effectiveness of a vitamin D3 oral spray solution with capsules at raising vitamin D status over winter.
This randomised crossover trial will aim to recruit a total of 22 healthy participants for a total of two 4-week interventions separated by a 10-week washout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy
- •Over the age of 18
排除标准
- •Those that intend to consume a supplement containing vitamin D at any point during the study
- •Those under the age of
- •Individuals that are on prescribed medication that is known to affect vitamin D metabolism
- •Those following a vegan diet
- •Sun-bed users
- •Participants that are planning a sun holiday during the study
研究组 & 干预措施
Vitamin D oral spray solution
An oral spray solution containing 3000IU (75micrograms) vitamin D3 per spray
干预措施: 3000IU(75μg) vitamin D3 (Dietary Supplement)
Vitamin D capsules
A capsule containing 3000IU (75micrograms) vitamin D3 per capsule
干预措施: 3000IU(75μg) vitamin D3 (Dietary Supplement)
结局指标
主要结局
Total 25-hydroxyvitamin D concentration
时间窗: At baseline and weeks 4, 14 and 18
Total 25-hydroxyvitamin D concentration will be determined using liquid chromatography-tandem mass spectrometry in collected serum samples
次要结局
- Biomarkers of vitamin D metabolism(At baseline and weeks 4, 14 and 18)
- Dietary vitamin D intake(At week 18 only)
研究者
Dr Pamela Magee
Dr Pamela Magee
University of Ulster
