Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue (MICI_2011-01)

Effects of Iron Therapy in Patients With Chronic Fatigue and IBD

A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron supplementation on chronic fatigue in IBD patients with controlled disease.

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Disease; Chronic Fatigue
• Intervention / Treatment: Drug: Placebo; Drug: Ferric carboxymaltose

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • IBD Center
      • Contact: Silvio Danese, MD, PhD; Phone Number: 5555 0039028224; Email: sdanese@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ferric carboxymaltose; Other Names: Ferinject
Placebo Comparator: Placebo; normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24.	Drug: Placebo; Other Names: Normal saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 6, 2015

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 9, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: fatigue; IBD; ulcerative colitis; iron; crohn's disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Fatigue; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 868