Influence of Vitamin D3 Supplementation on Infliximab Efficacy in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Serum 25 (OH) D level
研究概览
简要总结
Background: It remains uncertain whether vitD3 supplementation is beneficial for remission of Crohn's disease (CD). The influence of vitD3 supplementation on Infliximab (IFX) efficacy was retrospectively analyzed in Chinese CD patients. Methods: Patients with moderate-to-severe CD, who were bio-naïve and prescribed with IFX treatment for at least 54 weeks were recorded. VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. Disease activity was assessed using Harvey-Bradshaw Index (HBI). Serum cytokine profiles were quantitatively analyzed in a subset of all patients at baseline and 54-week after intervention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate-to-severe CD
- •Treated with Infliximab
- •bio-naïve at the time of diagnosis
排除标准
- •had recent supplementation of vitD3
- •had prior or concomitant use of other biologic agent, glucocorticoid and/or immunomodulators at the time of enrollment
- •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
研究组 & 干预措施
Vitamain D
This group of patients were supplemented with 125IU/d Vitamin D
干预措施: Caltrate Pill (Drug)
结局指标
主要结局
Serum 25 (OH) D level
时间窗: 54 weeks
Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.
disease activity
时间窗: 54 weeks
CDAI evaluation
次要结局
- the metabolism of calcium and phosphorus(54 weeks)
- the expression profiles of Th-cell-related cytokines(54 weeks)