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

Sponsor

Istituto Clinico Humanitas (Other)

Overall Status

Unknown status

CT.gov ID

NCT02517151

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Inflammatory Bowel Disease	Drug: Ferric carboxymaltose Drug: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Iron Therapy in Patients With Chronic Fatigue and IBD

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

May 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

chronic fatigue remission [Week 24]
Multidimensional fatigue inventory (MFI-20) <13

Secondary Outcome Measures

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
Quality of life [week 4, week 12, week 24]
Inflammatory Bowel Disease Questionnaire (IBDQ) values

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)