Retrospective Analysis of the Effect of Vitamin D Supplementation on the Clinical Efficacy of Vedelizumab in Ulcerative Colitis Patients
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
- disease activity
研究概览
简要总结
It is uncertain whether vitD3 supplementation is beneficial for the remission of ulcerative colitis (UC). The effects of vitD3 supplements on the efficacy of vidrecizumab in Chinese UC patients were retrospectively analyzed. Methods: Patients with moderate to severe UC were recorded. These patients were initially treated with VDZ. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of VDZ and continued throughout the follow-up period. Disease activity was assessed using the modified Mayo score.
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 UC
- •Treated with Vedolizumab
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
disease activity
时间窗: 30 weeks
modified Mayo score，mild: 3 to 5, moderate: 6 to 10, severe: 11 to 12
Serum 25 (OH) D level
时间窗: 30 weeks
Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.
次要结局
- drug survival(54 week)