Randomised, Double-blind, Double-dummy, Multicentre Trial to Evaluate the Efficacy and Safety of Three Different Weekly Dosages of Calcifediol Versus Placebo in Subjects With Either Vitamin D Deficiency or Insufficiency.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 674
- 试验地点
- 55
- 主要终点
- To assess efficacy for each cohort in terms of percentage of subjects achieving 25-OH-D levels ≥ 30 ng/mL and/or ≥ 20 ng/mL at 16 weeks of treatment.
研究概览
简要总结
This is a randomised, double-blind, double-dummy, multicentre, dose-ranging clinical trial in subjects with vitamin D deficiency or insufficiency. Its general objective is to determine the efficacy and safety of different doses of calcifediol soft gelatin capsules (SGCs) compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects ≥ 18 years of age.
- •Evidence of serum 25-OH-D levels < 20 ng/mL or ≤ 10 ng/mL, for each cohort.
- •Written informed consent.
- •For females of childbearing potential only: willing to perform pregnancy tests, must agree to use highly effective methods of birth control throughout the study.
排除标准
- •Subjects receiving any treatment with calcifediol, vitamin D analogues, vitamin complexes or vitamin D supplements.
- •Subjects taking drugs that could modify vitamin D levels.
- •Subjects taking calcium supplements.
- •Uncorrected hypercalcaemia, known hypercalciuria or nephrolithiasis.
- •Severe renal impairment.
- •Subjects diagnosed with liver or biliary failure, congestive heart failure, malabsorption, primary hyperparathyroidism, hypothyroidism, prolonged immobilisation, sarcoidosis, tuberculosis or other granulomatous diseases or hyperthyroidism.
- •Any present or previous malignancy.
- •Known contraindications or sensitivities to the use of the IP or any of its components.
- •Pregnant woman, breastfeeding woman or woman planning a pregnancy.
- •Subject has received an IP within 30 days before the start of the screening or is currently enrolled in an investigational interventional study.
- •Any condition that may jeopardise the clinical trial conduct according to the protocol.
- •Employees of the investigator or clinical trial site, as well as family members of the employees or the principal investigator.
- •Person committed to an institution by virtue of an order issued either by judicial or other authorities.
研究组 & 干预措施
Group 1A
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
干预措施: Placebo (Other)
Group 1B
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
干预措施: Calcifediol 75mcg (Drug)
Group 1B
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
干预措施: Placebo (Other)
Group 1C
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
干预措施: Calcifediol 100mcg (Drug)
Group 1C
Subjects corresponding to Cohort 1 (25-OH-D baseline level > 10 to < 20 ng/mL)
干预措施: Placebo (Other)
Group 2A
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
干预措施: Placebo (Other)
Group 2B
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
干预措施: Calcifediol 100mcg (Drug)
Group 2B
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
干预措施: Placebo (Other)
Group 2C
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
干预措施: Calcifediol 125mcg (Drug)
Group 2C
Subjects corresponding to Cohort 2 (25-OH-D baseline level ≤ 10 ng/mL)
干预措施: Placebo (Other)
结局指标
主要结局
To assess efficacy for each cohort in terms of percentage of subjects achieving 25-OH-D levels ≥ 30 ng/mL and/or ≥ 20 ng/mL at 16 weeks of treatment.
时间窗: 16 weeks
Percentage of subjects who achieve 25-OH-D levels ≥ 30 ng/mL and/or ≥ 20 ng/mL
次要结局
未报告次要终点