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临床试验/NCT03457571
NCT03457571已完成不适用

Clinical Observational Study: IBD Patients With Restless-legs-syndrome and Iron Deficiency Syndrome

Charite University, Berlin, Germany0 个研究点目标入组 353 人开始时间: 2014年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
353
主要终点
Prevalence of RLS in IBD

研究概览

简要总结

Patients with inflammatory bowel disease, such as Crohn´s disease or ulcerative colitis, have recurring episodes of abdominal pain, diarrhea and loss of weight. Besides this other clinical symptoms are possible e.g. deficiency syndromes such as iron deficiency. Iron deficiency usually attended by symptoms like hair loss, pale skin, loss of concentration or fatigue. In some cases iron deficiency can lead to neurological manifestations such as restless-legs-syndrome (RLS). Restless legs syndrome is a neurological disorders which is accompanied by substantial urge to move legs or other parts of the body and unpleasant sensations.

Aim of this study is to to investigate the prevalence of RLS in patients with inflammatory bowel disease and furthermore evaluate the effect of iron supplementation in patients with iron deficiency and concomitant RLS.

详细描述

Restless legs syndrome (RLS) is a common neurological disease significantly impacting live quality. Two recent studies from North America and Japan revealed a surprisingly high prevalence for RLS in Crohn´s disease and ulcerative colitis (30% and 21%, respectively). The underlying cause for this high prevalence remains elusive at this point.

To address this gap, a cohort of 353 IBD patients from a tertiary IBD centre was prospectively evaluated by our IBD team as well as by the colleagues from neurology. IBD patients (age ≥ 18 years) presenting at our IBD outpatient clinic (tertiary referral center) between February 2014 and February 2015 were prospectively recruited for the study after written consent. The study was approved (16 January 2014) by the ethics committee of the Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin (reference EA4/132/13). Patients were screened for symptoms of iron deficiency (ID) and RLS by a self-developed questionnaire and explored for RLS symptoms by a gastroenterologist. When at least one symptom of RLS was present, patients were referred to a neurologist for RLS or differential diagnosis.

Additionally patients with RLS symptoms were screened for iron-, folic acid- and vitamin B12-deficiency. If a deficiency was detected, patients were substituted. In patients with deficiencies, follow-up visits were scheduled at week 4 and 11 after starting supplementation. Follow-up visits were conducted by the neurologist and the IRLS was performed in all patients at each visit.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Written consent
  • Age > 18
  • Inflammatory bowel disease

排除标准

  • <18 years
  • No written consent

结局指标

主要结局

Prevalence of RLS in IBD

时间窗: 1 year

次要结局

  • Prevalence of clinically relevant RLS in IBD(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Janek Becker

MD

Charite University, Berlin, Germany

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