Optimal Substitution Dose of the Vitamin D During Winter Time in Patient With Inflammatory Bowel Diseases (IBD)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Change in vitamin D blood level after follow-up interval
研究概览
简要总结
The purpose of this study is to confirm anticipated substitution dose of the vitamin D for sustained blood level during winter time in patients with inflammatory bowel diseases (IBD)
详细描述
Vitamin D substitution is widely recommended. Suggested substitution doses are increasing over the time. No exact body requirement is known for patients with IBD at present. Aim of the study was to confirm substitution dose obtained from model.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with inflammatory bowel disease
排除标准
- •Liver disease
- •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
IU/Day
This is standard dose of the drug (colecalciferol), which is not calculated in relation to patient body weight
干预措施: Colecalciferol (Drug)
IU/Kg/Day
This is dose of the drug (colecalciferol), which is based or calculated in relation to patient actual body weight
干预措施: Colecalciferol (Drug)
结局指标
主要结局
Change in vitamin D blood level after follow-up interval
时间窗: 4 Months
Change of the D vitamin level after follow-up interval in groups substituted according to weight or in fixed daily dose.
次要结局
- Change in vitamin D after follow-up interval according to weight(4 Months)
研究者
MUDr. Jan Matous
Jan Matous, MD
Faculty Hospital Kralovske Vinohrady