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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Fatigue, Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: Ferric carboxymaltose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Ulcerative Colitis or Crohn's Disease established at least 6 months prior to Day 1 by endoscopy and/or imaging At least 6 months of clinical remission (Harvey Bradshaw Index ≤5; Mayo clinical score ≤ 2) Therapy with mesalamine, immunosuppressors or anti-tumor necrosis factor alpha (TNFα) at stable doses for at least 3 months prior enrollment; steroids are not permitted from 6 months prior baseline Chronic fatigue symptoms (MFI-20>13) Iron deficiency: ferritin < 100 microg/l or < 300 microg/l in case of Transferrin-Iron Saturation Percentage (TSAT) <20% Women of childbearing potential must have a negative serum pregnancy test before enrollment. Able and willing to provide written informed consent Exclusion Criteria: Known hypersensibility to active principle or excipients Pregnant or lactating women Clinically active IBD (Harvey Bradshaw Index >6; Mayo clinical score >3 or C-Reactive Protein >2.5 mg/L Renal failure (eGFR<60) History of adrenal insufficiency History of autoimmune diseases History of malignancies Depression Any current or recent signs or symptoms of viral infectious diseases Recent psycho-traumatic events Hemoglobin levels < 12.5 g/dl (men) or <11.5 g/dL (women)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferric carboxymaltose<br>200 mg in normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24. | Drug: Ferric carboxymaltose<br> <br> * Other names: Ferinject;|
| Placebo Comparator: Placebo<br>normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24. | Drug: Placebo<br> <br> * Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic fatigue remission | Multidimensional fatigue inventory (MFI-20) <13 | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic fatigue reduction | MFI-20 reduction of at least 4 points (absolute MFI-20>13) | Week 24 | 
| chronic fatigue remission | MFI-20 <13 | Week 12 | 
| Anxiety evaluation | State-Trait Anxiety Inventory (STAI)Y1 and STAI Y2 values | week 4, week 12, week 24 | 
| Depression evaluation | BECK DEPRESSION INVENTORY (BDI-II) values | week 4, week 12, week 24 | 
| Quality of life | Inflammatory Bowel Disease Questionnaire (IBDQ) values | week 4, week 12, week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iron, fatigue, crohn's disease, ulcerative colitis, IBD