NL-OMON24663已完成不适用
A randomized, double-blinded placebo controlled trial to evaluate the efficacy of a multivitamin and mineral supplement to prevent infections in patients with inflammatory bowel disease.
ew Care0 个研究点目标入组 320 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •? Patients between the ages of 18 and 75 years old.
- •? Patients diagnosed with Crohn’s disease or Ulcerative Colitis.
- •? Patients using immunomodulators (azathiopurine, mercaptopurine and thioguanine) and/ or anti-TNF therapy (infliximab, adalimumab, golimumab).
排除标准
- •Patients with active inflammation. Disease has to be in remission defined as CRP = 10mg/l, leucocytes between 4.0-10.0 10E9/l and feces calprotectin levels of = 100µg/g.
- •Patients whose laboratory values not within the reference ranges ; chemistry panel, renal function, hepatic function, vitamin B12 and albumin, including but not limited to hemoglobin, iron (> 8µmol/L) and folic acid levels (> 9nmol/L).
- •Patients who used vitamin supplements, antibiotics or Non-Steroidal Anti- Inflammatory Drugs (NSAIDs) in the 4 weeks prior to the screening visit, or are planning to do so during the study period.
- •Patients who are pregnant, lactating or planning pregnancy while enrolled in the study. (The investigational product contains caffeine which can be harmful for the unborn and newborn child.)
- •Patients who are unsuitable for inclusion in the study in the opinion of the investigator for any reason that may compromise the subject’s safety or confound data interpretation.
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