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Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue — MICI_2011-01  

Inflammatory Bowel Disease Clinical Trial

Official title:
Effects of Iron Therapy in Patients With Chronic Fatigue and IBD

Clinical Trial Summary

A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron supplementation on chronic fatigue in IBD patients with controlled disease.

Clinical Trial Description

The study will evaluate a 6 months therapy with intravenous ferric carboxymaltose.

Patients will undergo a 2-5 days screening period and then will be treated every 4 weeks with iron supplementation/placebo.

At every visit, hematology and blood iron levels will be evaluated. Treatment will be temporarily stopped in case of either Hemoglobin levels above 16 g/dl or ferritin above 800 ng/ml (level decreased to 500 ng/ml in case of Transferrin-Iron Saturation Percentage above 50%).

Study team will be composed of blinded and unblinded personnel and dedicated infusion devices will be used to ensure the double blinding. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02517151
Study type Interventional
Source Istituto Clinico Humanitas
Contact Silvio Danese, MD, PhD
Phone +39 02 8224
Email IBDclinicaltrials@humanitas.it
Status Recruiting
Phase Phase 2
Start date October 2014
Completion date December 2016
View Details
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