Iron Supplementation in Inflammatory Bowel Disease (IBD)... | NCT02517151

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

NCT02517151

Sponsor

Istituto Clinico Humanitas

Status

Unknown status

Last Update Posted

Sep 10, 2015Estimated

Enrollment

36Estimated

Phase

Phase 2

Conditions

Chronic Fatigue
Inflammatory Bowel Disease

Interventions

Ferric carboxymaltose
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

May 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Aug 4, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2015

Last Update Posted Date

Sep 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ferric carboxymaltose	Drug		Ferric carboxymaltose	Ferinject
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
chronic fatigue remission	Multidimensional fatigue inventory (MFI-20) <13	Week 24

Secondary Outcomes

Measure	Description	Time Frame
Chronic fatigue reduction	MFI-20 reduction of at least 4 points (absolute MFI-20>13)	Week 24
chronic fatigue remission	MFI-20 <13

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Silvio Danese, MD, PhD	Contact	+39 02 8224	5555	IBDclinicaltrials@humanitas.it

Facility	Status	City	State	ZIP	Country	Contacts
IBD Center	Recruiting	Rozzano	MI	20089	Italy

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005221	Fatigue
D003424	Crohn Disease
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522335	ferric carboxymaltose
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided