Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- number of patients with remission
研究概览
简要总结
Ulcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased permeability. Several cytokines are described to mediate the progressive course of ulcerative colitis and it is considered nowadays an immunologic disease. Patients with UC have often low levels of vitamin D and elevated prevalence of osteoporosis.
In vitro studies demonstrate that vitamin D has an immunomodulating effect, and may have a direct healing action on colonic mucosa has been described in animal studies. One can therefore rise a hypothesis that vitamin D supplementation could be crucial in patients with UC. To our knowledge, it has not been performed randomized clinical trials to study these possible effects of vitamin D and it has not been studied the effects of vitamin D on the relapse frequency and immunological composition of colic mucosa in patient with moderate to severe ulcerative colitis.
Objectives for our study are as follows: To examine if high-dose vitamin D supplementation in patients with moderate to severe ulcerative colitis:
- reduces relapse frequency and increase the duration of the Infliximab induced remission
- mediates and changes the cytokines composition in the colic mucosa
- decreases the excretion of calprotectin in feces and reduces the concentration of inflammation markers
- augments bone mass
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
- •Men and women older than18 years old, diagnosed with UC (either debut or relapsed chronic UC), moderate or severe, where it is an indication to treat with infliximab.
排除标准
- •Primary hyperparathyroidism (PHPT)
- •Sarcoidosis
- •Renal failure (serum creatinine > 125 mumol/L in men or > 105 mumol/L in women)
- •Those, who use solarium routinely are not included
- •Pregnant or breastfeeding women, otherwise women of fertile age must be on approved birth control methods during the study
- •Renal stones last 15 years
- •Cancer of any origin, diagnosed during last 5 years
- •Unstable angina pectoris
研究组 & 干预措施
Vitamin D
Decristol (cholecalciferol) 20000 IU per capsule
1 capsule per week
干预措施: Vitamin D (Drug)
Placebo
capsule with peanut oil
干预措施: placebo (Drug)
结局指标
主要结局
number of patients with remission
时间窗: 12 months after start of intervention
Mandatory criterion of remission: clinical remission (defined as Mayo score \<= 1, including endoscopic findings) and non-mandatory: laboratory (calprotectin \< 100, WBC and SR within reference range). These criteria will be assessed at 12 month after the start of intervention
次要结局
- change in tnf-alpha levels in colonic mucosa(3 months)
- change in tnf-alpha (in colonic mucosa)(12 months after baseline)
- change in fecal calprotectin(3 months)
- change in bone mineral density (whole body)(12 months after the start of intervention)