NCT05733117招募中4 期
Supplementation Efficacy Comparing the Oral Nano and Conventional Vitamin D in Inflammatory Bowel Disease
Tomas Bata Hospital, Czech Republic2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年10月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Vitamin D (25OHD) blood level
研究概览
简要总结
The purpose of this study is to compare efficacy of the suplementation using the conventional oral and oral nano form of the calciferol.
详细描述
Conventional oral vit D formulas have variable availability esp. in IBD patients. Oral nano vitamin D is absorbed in the mouth. The aim of this study is to compare the efficacy of both formulations by matching vitD levels after supplementation and to determine the equivalent dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inflammatory bowel disease patients
排除标准
- •Liver and renal disease
- •Hypercalcemia
- •Hyperparathyreoidism
- •Chronic pancreatitis
- •Concomitant vitamin D medication
- •Pregnancy
- •Sarcoidosis
- •Malignancy
- •Inability to obtain valid data from subject
研究组 & 干预措施
NanoVitD
Active Comparator
Oral nano form of the calciferol
干预措施: Vitamin D (Drug)
ConvVitD
Active Comparator
Conventional oral calciferol
干预措施: Vitamin D (Drug)
结局指标
主要结局
Vitamin D (25OHD) blood level
时间窗: 4 months
Change of the D vitamin level after follow-up interval
次要结局
未报告次要终点
研究者
Vladimir Kojecky, MD, Ph.D.
Head of dept. of internal medicine
Tomas Bata Hospital, Czech Republic
研究点 (2)
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