NCT02517151

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

1.6 years

First QC Date

August 4, 2015

Last Update Submit

September 9, 2015

Conditions

Chronic FatigueInflammatory Bowel Disease

Keywords

ironfatiguecrohn's diseaseulcerative colitisIBD

Outcome Measures

Primary Outcomes (1)

  • chronic fatigue remission

    Multidimensional fatigue inventory (MFI-20) \<13

    Week 24

Secondary Outcomes (5)

  • Chronic fatigue reduction

    Week 24

  • chronic fatigue remission

    Week 12

  • Anxiety evaluation

    week 4, week 12, week 24

  • Depression evaluation

    week 4, week 12, week 24

  • Quality of life

    week 4, week 12, week 24

Study Arms (2)

Ferric carboxymaltose

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ferric carboxymaltoseDRUG
Also known as: Ferinject
Ferric carboxymaltose
PlaceboDRUG
Also known as: Normal saline
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IBD Center

Rozzano, MI, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel DiseasesFatigueCrohn DiseaseColitis, Ulcerative

Interventions

ferric carboxymaltoseSaline Solution

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsColitisColonic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Silvio Danese, MD, PhD

CONTACT

+39 02 8224IBDclinicaltrials@humanitas.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 6, 2015

Study Start

October 1, 2014

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

IT(1)