Clinical trial NCT02517151: Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue
Official title: Effects of Iron Therapy in Patients With Chronic Fatigue and IBD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Fatigue
Inflammatory Bowel Disease
Keywords: iron
fatigue
crohn's disease
ulcerative colitis
IBD
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: chronic fatigue remission
timeFrame: Week 24
Secondary outcomes:
measure: Chronic fatigue reduction
timeFrame: Week 24
measure: chronic fatigue remission
timeFrame: Week 12
measure: Anxiety evaluation
timeFrame: week 4, week 12, week 24
measure: Depression evaluation
timeFrame: week 4, week 12, week 24
measure: Quality of life
timeFrame: week 4, week 12, week 24
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IBD Center
state: MI
Study officials:
References: