The Effects of Eight Weeks of Supplementation With Two Vitamin D₃ Formulations in Adults With Subclinical and Clinical Vitamin D Deficiency: A Randomized Controlled Superiority Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 25(OH)D
研究概览
简要总结
This randomized controlled superiority pilot trial will evaluate the efficacy of two vitamin D3 formulations administered over eight weeks in adults with subclinical or clinical vitamin D deficiency. The study will compare changes in serum 25-hydroxyvitamin D concentrations between formulations, as well as the proportion of participants who will achieve vitamin D sufficiency. Both formulations are expected to improve vitamin D status, with the hypothesis that one formulation will demonstrate superior bioavailability, resulting in greater and faster increases in circulating 25-hydroxyvitamin D. The findings will provide preliminary evidence to inform formulation selection and dosing strategies for correcting vitamin D deficiency and will support the design of larger, confirmatory trials.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and over
- •Serum 25(OH)D < 75 nmol/L
- •BMI 18.5 - 29.9 kg/m2
- •Free of clinically significant acute disorders and severe chronic diseases
- •No planned travel to high-UV destinations or tanning bed use during the trial
- •Willing to avoid non-study vitamin D supplements
- •Able to give written informed consent and comply with study visits
- •Submitted informed consent
排除标准
- •Pregnancy of breast feeding
- •Underweight or obesity
- •History of any dietary supplement use within 8 weeks before screening
- •Medications that materially alter vitamin D metabolism or calcium balance
- •Subjects with a history of medicine or alcohol abuse
- •Abnormal values for lab clinical chemistry (> 2 SD)
- •Unwillingness to return for follow-up analysis
- •Participation in other clinical trials within 60 days prior to screening
结局指标
主要结局
25(OH)D
时间窗: Change from baseline 25(OH)D at 8 weeks
Serum levels of 25(OH)D
次要结局
- Total calcium(Change from total calcium at 8 weeks)
- Ionized calcium(Change from ionized calcium at 8 weeks)
- Phosphorus(Change from phosphorus at 8 weeks)
- Magnesium(Change from magnesium at 8 weeks)