Vitamin D Treatment in Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mucosal Permeability
研究概览
简要总结
The purpose of this study is to test blood and tissue samples of people with Ulcerative Colitis (UC) to see what effects Vitamin D3 may have on the immune system. This research is being done because it could lead to the development of new treatment for people with Inflammatory Bowel Disease (IBD).
详细描述
The primary endpoint of the trial is the change in colonic permeability as a global assessment of vitamin D3 effects throughout the colon in patients with Ulcerative Colitis. Secondary endpoints will be changes in colonic tight junction protein expression, and their relationship to serum vitamin D level, VDR expression, inflammatory cytokines, and histologic inflammation
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients must be over 18 years of age
- •have a diagnosis of UC as confirmed by histology.
- •UC patients must have active but mild disease as confirmed by a Mayo Clinic endoscopy score from 2-4,
- •not requiring medication adjustment during the trial.
- •Patients must be capable of understanding the purpose, risks and expectations of study participation and willing to provide written informed consent.
排除标准
- •Individuals on vitamin D or laxative therapy (except for purposes of endoscopy preparation),
- •UC patients with fulminant colitis or active C difficile or other colonic infections,
- •age<18 year old,
- •individuals with bleeding disorders will be excluded from the study.
研究组 & 干预措施
Vitamin D
Subjects will take 1 pill per day for 8 weeks.
干预措施: Vitamin D3 (Drug)
Placebo
Subjects will be asked to take 1 pill per day for 8 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Mucosal Permeability
时间窗: 8 weeks
The primary endpoint of the trial is the change in colonic permeability as a global assessment of vitamin D3 effects throughout the colon in patients with Ulcerative Colitis.
次要结局
- Mucosal tight junction protein expression(8 weeks)