NCT02517151

Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue

Effects of Iron Therapy in Patients With Chronic Fatigue and IBD

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Fatigue
• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	Ferric carboxymaltose
DRUG	Placebo

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-05-01
• Completion: 2016-12-01
• First posted: 2015-08-06
• Last updated: 2015-09-10

Locations

1 site across 1 country: Italy