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

Inflammatory Bowel Disease Clinical Trial

— MICI_2011-01  

Official title:

Effects of Iron Therapy in Patients With Chronic Fatigue and IBD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02517151
• Other study ID #: 868
• Status: Recruiting
• Phase: Phase 2
• First received: August 4, 2015
• Last updated: September 9, 2015
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2015
• Source: Istituto Clinico Humanitas
• Contact: Silvio Danese, MD, PhD
• Phone: +39 02 8224
• Email: IBDclinicaltrials[@]humanitas.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 (TNFa) 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue
• Fatigue
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Ferric carboxymaltose

• Placebo

Locations

Country	Name	City	State
Italy	IBD Center	Rozzano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chronic fatigue remission	Multidimensional fatigue inventory (MFI-20) <13	Week 24	No
Secondary	Chronic fatigue reduction	MFI-20 reduction of at least 4 points (absolute MFI-20>13)	Week 24	No
Secondary	chronic fatigue remission	MFI-20 <13	Week 12	No
Secondary	Anxiety evaluation	State-Trait Anxiety Inventory (STAI)Y1 and STAI Y2 values	week 4, week 12, week 24	No
Secondary	Depression evaluation	BECK DEPRESSION INVENTORY (BDI-II) values	week 4, week 12, week 24	No
Secondary	Quality of life	Inflammatory Bowel Disease Questionnaire (IBDQ) values	week 4, week 12, week 24	No