The Effect of Oral Loading Doses of Cholecalciferol on the Serum Concentration of 25-OH-vitamin-D
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Change in baseline value of [25-OH-vitamin-D]
研究概览
简要总结
Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our objective was to determine how to calculate the quantity of cholecalciferol needed for supplementation by single algorithm, usable on a patient-to-patient basis.
We've conducted two studies. Study 1 was done retroactively and included 88 patients treated for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and aimed to test the validity of an algorithm based on data from study 1, which included patient BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •severe hypovitaminosis D (25OH-vit.D <25 nmol/L)
排除标准
- •Malabsorption
- •Renal disease
- •Other treatment with vitamin D related products
- •Patients with a recent travel history with suspected increased sun exposure
研究组 & 干预措施
Loading dose substitution
Substituted with a highdose of cholecalciferol at study start
干预措施: Cholecalciferol (Drug)
结局指标
主要结局
Change in baseline value of [25-OH-vitamin-D]
时间窗: 1 week, 3 weeks and 3 months
次要结局
未报告次要终点