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

Phase 2

• Conditions: Inflammatory Bowel Disease; Chronic Fatigue
• Interventions: Drug: Placebo; Drug: Ferric carboxymaltose

• Registration Number: NCT02517151
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-10
• Primary Completion: 2016-05
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24.
Ferric carboxymaltose	Ferric carboxymaltose	200 mg in normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24.

Primary Outcome Measures

Name	Time	Method
chronic fatigue remission	Week 24	Multidimensional fatigue inventory (MFI-20) \<13

Secondary Outcome Measures

Name	Time	Method
Quality of life	week 4, week 12, week 24	Inflammatory Bowel Disease Questionnaire (IBDQ) values
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

Trial Locations

Locations (1)

IBD Center; 🇮🇹 Rozzano, MI, Italy