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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457571
• Other study ID #: EA4/132/13
• Status: Completed
• Phase: N/A
• First received: March 1, 2018
• Last updated: March 6, 2018
• Start date: February 1, 2014
• Est. completion date: April 30, 2015

Study information

• Verified date: March 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: April 30, 2015
• Est. primary completion date: February 28, 2015
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written consent

• Age > 18

• Inflammatory bowel disease

Exclusion Criteria:

• <18 years

• No written consent

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Inflammatory Bowel Diseases
• Iron-deficiency
• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of RLS in IBD		1 year
Secondary	Prevalence of clinically relevant RLS in IBD		1 year