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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
IBD Center
Rozzano, MI, Italy
RECRUITINGchronic fatigue remission
Multidimensional fatigue inventory (MFI-20) \<13
Time frame: Week 24
Chronic fatigue reduction
MFI-20 reduction of at least 4 points (absolute MFI-20\>13)
Time frame: Week 24
chronic fatigue remission
MFI-20 \<13
Time frame: Week 12
Anxiety evaluation
State-Trait Anxiety Inventory (STAI)Y1 and STAI Y2 values
Time frame: week 4, week 12, week 24
Depression evaluation
BECK DEPRESSION INVENTORY (BDI-II) values
Time frame: week 4, week 12, week 24
Quality of life
Inflammatory Bowel Disease Questionnaire (IBDQ) values
Time frame: week 4, week 12, week 24
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