The Efficacy of Different Vitamin D Supplementation Delivery Methods on Serum 25(OH)D in Humans a Randomised Double-blind Placebo Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- serum 25(OH)D
研究概览
简要总结
To test the efficacy of different vitamin D delivery methods on serum 25(OH)D. Participants randomly assigned to one of seven groups - three placebo groups and 4 active supplement groups receiving 100,000IU vitamin D3
详细描述
Various delivery methods of vitamin D supplementation are available to consumers but there have been no studies providing evidence of whether one delivery method is superior to others. The researchers wanted to compare the delivery of 100,000IU vitamin D3 by three methods on serum 25(OH)D levels. Two methods of oral supplementation (pill [prolonged release] and liquid [immediate release]), and delivery through the skin (with and without a penetrator enhancer. Placebo groups were pill, oral liquid and skin applied oil
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy, female
排除标准
- •any participant that was taking vitamin supplementation, had a skin condition that would prevent them from applying oil to their skin or were taking, or had been taking in the past 6-months, oestrogen based contraception
研究组 & 干预措施
Vitamin D3 oral liquid
100 drops = 100,000IU in orange syrup
干预措施: vitamin D3 (Dietary Supplement)
Vitamin D3 pill
100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
干预措施: Pill (Dietary Supplement)
Pill placebo
100 pills = Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
干预措施: Pill (Dietary Supplement)
Vitamin D3 pill
100 pills = 100,000IU + Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
干预措施: vitamin D3 (Dietary Supplement)
Vitamin D3 oral liquid
100 drops = 100,000IU in orange syrup
干预措施: orange syrup (Dietary Supplement)
Oral liquid placebo
100 drops orange syrup
干预措施: orange syrup (Dietary Supplement)
Skin oil + Vitamin D3 + penetrator
100,000IU + mineral oil+ Tangerine essential oil (10ml)
干预措施: Penetrator (Dietary Supplement)
Skin oil placebo
Skin application: 100ml of mineral oil coloured with food colourant to match active oil sample
干预措施: mineral oil (Other)
Skin oil + Vitamin D3
100,000IU + mineral oil
干预措施: vitamin D3 (Dietary Supplement)
Skin oil + Vitamin D3
100,000IU + mineral oil
干预措施: mineral oil (Other)
Skin oil + Vitamin D3 + penetrator
100,000IU + mineral oil+ Tangerine essential oil (10ml)
干预措施: vitamin D3 (Dietary Supplement)
Skin oil + Vitamin D3 + penetrator
100,000IU + mineral oil+ Tangerine essential oil (10ml)
干预措施: mineral oil (Other)
结局指标
主要结局
serum 25(OH)D
时间窗: 4 weeks
Changes in serum 25(OH)D levels
次要结局
未报告次要终点
研究者
Matthew Wyon
Professor Matthew Wyon
University of Wolverhampton