NCT05867784已完成不适用
Effect of Vitamin D Supplementation on the Efficacy of Ustekinumab in the Treatment of Crohn's Disease
Second Affiliated Hospital of Wenzhou Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年4月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Serum 25 (OH) D level
研究概览
简要总结
It is uncertain whether vitD3 supplementation is beneficial for the remission of Crohn's disease (CD). The effects of vitD3 supplements on the efficacy of ustekinumab in Chinese CD patients were retrospectively analyzed. Methods: Patients with moderate to severe CD were recorded. These patients were initially treated with UST. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of UST and continued throughout the follow-up period. Disease activity was assessed using Harvey Bradshaw Index.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate-to-severe CD
- •Treated with Ustekinumab
排除标准
- •had recent supplementation of vitD3
- •had cognitive/developmental disorders that affected their ability to complete the study procedures
- •had medical illness or therapies potentially affecting bone, nutrition or growth status
- •unknown or untested baseline serum 25(OH)D level
结局指标
主要结局
Serum 25 (OH) D level
时间窗: 24 weeks
Vitamin D deficiency is defined as serum 25 (OH) D level\<20 μ g/L
disease activity
时间窗: 24weeks
Harvey Bradshaw Index，mild: 0 to 8, moderate: 9 to 16, severe: 17 to 25
次要结局
- Serum 25 (OH) D level(8 weeks)
研究者
研究点 (1)
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