Chronic Fatigue, Inflammatory Bowel Disease
Conditions
Keywords
iron, fatigue, crohn's disease, ulcerative colitis, IBD
Brief 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.
Interventions
DRUGFerric carboxymaltose
DRUGPlacebo
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| chronic fatigue remission | Week 24 | Multidimensional fatigue inventory (MFI-20) \<13 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic fatigue reduction | Week 24 | MFI-20 reduction of at least 4 points (absolute MFI-20\>13) |
| chronic fatigue remission | Week 12 | MFI-20 \<13 |
| Anxiety evaluation | week 4, week 12, week 24 | State-Trait Anxiety Inventory (STAI)Y1 and STAI Y2 values |
| Depression evaluation | week 4, week 12, week 24 | BECK DEPRESSION INVENTORY (BDI-II) values |
| Quality of life | week 4, week 12, week 24 | Inflammatory Bowel Disease Questionnaire (IBDQ) values |
Countries
Italy
Contacts
Primary ContactSilvio Danese, MD, PhD
Outcome results
None listed