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

Primary Purpose

Chronic Fatigue, Inflammatory Bowel Disease

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Ferric carboxymaltose
Placebo
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Fatigue focused on measuring iron, fatigue, crohn's disease, ulcerative colitis, IBD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • IBD CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ferric carboxymaltose

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

chronic fatigue remission
Multidimensional fatigue inventory (MFI-20) <13

Secondary Outcome Measures

Chronic fatigue reduction
MFI-20 reduction of at least 4 points (absolute MFI-20>13)
chronic fatigue remission
MFI-20 <13
Anxiety evaluation
State-Trait Anxiety Inventory (STAI)Y1 and STAI Y2 values
Depression evaluation
BECK DEPRESSION INVENTORY (BDI-II) values
Quality of life
Inflammatory Bowel Disease Questionnaire (IBDQ) values

Full Information

First Posted
August 4, 2015
Last Updated
September 9, 2015
Sponsor
Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT02517151
Brief Title
Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue
Acronym
MICI_2011-01
Official Title
Effects of Iron Therapy in Patients With Chronic Fatigue and IBD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue, Inflammatory Bowel Disease
Keywords
iron, fatigue, crohn's disease, ulcerative colitis, IBD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ferric carboxymaltose
Arm Type
Experimental
Arm Description
200 mg in normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24.
Intervention Type
Drug
Intervention Name(s)
Ferric carboxymaltose
Other Intervention Name(s)
Ferinject
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Primary Outcome Measure Information:
Title
chronic fatigue remission
Description
Multidimensional fatigue inventory (MFI-20) <13
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Chronic fatigue reduction
Description
MFI-20 reduction of at least 4 points (absolute MFI-20>13)
Time Frame
Week 24
Title
chronic fatigue remission
Description
MFI-20 <13
Time Frame
Week 12
Title
Anxiety evaluation
Description
State-Trait Anxiety Inventory (STAI)Y1 and STAI Y2 values
Time Frame
week 4, week 12, week 24
Title
Depression evaluation
Description
BECK DEPRESSION INVENTORY (BDI-II) values
Time Frame
week 4, week 12, week 24
Title
Quality of life
Description
Inflammatory Bowel Disease Questionnaire (IBDQ) values
Time Frame
week 4, week 12, week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvio Danese, MD, PhD
Phone
+39 02 8224
Ext
5555
Email
IBDclinicaltrials@humanitas.it
Facility Information:
Facility Name
IBD Center
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvio Danese, MD, PhD
Phone
0039028224
Ext
5555
Email
sdanese@hotmail.com

12. IPD Sharing Statement

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

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