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

NCT ID: NCT02517151

Last Updated: 2015-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-12-31

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.

Conditions

Chronic Fatigue; Inflammatory Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ferric carboxymaltose

Intervention Type: DRUG

Placebo

normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Ferric carboxymaltose

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Ferinject; Normal saline

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IBD Center

Rozzano, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Silvio Danese, MD, PhD

Role: CONTACT

IBDclinicaltrials@humanitas.it

+39 02 8224 ext. 5555

Facility Contacts

Silvio Danese, MD, PhD

Role: primary

sdanese@hotmail.com

0039028224 ext. 5555

Other Identifiers

868

Identifier Type: -

Identifier Source: org_study_id