Inflammatory Bowel Disease Clinical Trial
Official title:
Effects of Iron Therapy in Patients With Chronic Fatigue and IBD
A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron supplementation on chronic fatigue in IBD patients with controlled disease.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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