Vitamin D 24'000 IU for Oral Intermittent Supplementation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Serum level of vitamin D
研究概览
简要总结
Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/l) is cured with oral supplementation. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly (24'000 IU) or weekly (5'600 IU) is possible. Commercially available intermittent pharmaceutical forms in Switzerland are liquid (oily or alcoholic solution). The study aims to compare the rise of vitamin D3 levels after treatment between newly developed soft capsules and monthly solution (primary outcome), and to evaluate the effect of a loading dose (without infringing the cumulative maximal dose of 4'000 IU per day) on the achievement of optimal values >75 nmol/l (secondary outcome). The investigators will use newly developed soft capsules and alcoholic solution, which are commercially available in Switzerland.
详细描述
Group Control, Alcoholic Drinking Solution: 5 ml of an alcoholic drinking solution with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).
Group IMP, Capsules: one capsule with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).
Group IMP + loading dose, Loading Dose: one capsule with 24'000 IU vitamin D p.o. once a week during an individually calculated number of weeks.
All 3 groups: Measurement of vitamin D in serum before therapy and one week after the last dose.
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
- 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
- 否
入选标准
- •vitamin D deficiency by serum level <50 nmol/l
排除标准
- •hypercalcaemia
研究组 & 干预措施
Control
5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months
干预措施: Vitamin D3 (Drug)
IMP
Vitamin D oily capsules containing 24'000 IU vitamin D for 3 months
干预措施: Vitamin D oily capsules (Drug)
IMP + loading dose
Vitamin D oily capsules containing 24'000 IU vitamin D for an individual number of weeks calculated with the formula: 40 x (100 - actual value [nmol/l] x body weight [kg] / 24'000 IU.
干预措施: Vitamin D oily capsules (Drug)
结局指标
主要结局
Serum level of vitamin D
时间窗: 3 months of treatment
Level of serum vitamin D after 3 month treatment compared to baseline value
次要结局
- Serum level of vitamin D after loading dose(up to 4 months of treatment)
- Adverse Drug Reactions(3 months of treatment)
- Adherence to medication(3 months of treatment)