Chronic FatiguePhase 2MICI_2011-01NCT02517151
Iron Supplementation in Inflammatory Bowel Disease (IBD) Patients With Chronic Fatigue
A Phase 2 study testing Ferric carboxymaltose in people with Chronic Fatigue and Inflammatory Bowel Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Fatigue, Inflammatory Bowel Disease
- What is being tested?
- Ferric carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IBD Center
Rozzano, MI, 20089
Silvio Danese, MD, PhD, 0039028224 ext. 5555, sdanese@hotmail.com
About this study
Official title: Effects of Iron Therapy in Patients With Chronic Fatigue and IBD
A phase 2, randomized, placebo controlled trial evaluating the effects of n intravenous iron supplementation on chronic fatigue in IBD patients with controlled disease.
Read the 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
- Being tested
- Ferric carboxymaltose, Placebo
- Keywords
- iron, fatigue, crohn's disease, ulcerative colitis, IBD
- Medical subject headings
- Inflammatory Bowel Diseases, Fatigue, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called Ferinject
PlaceboDrug
Also called Normal saline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic fatigue remission
Multidimensional fatigue inventory (MFI-20) <13
Measured: Week 24
Secondary outcomes (5)
Chronic fatigue reduction
MFI-20 reduction of at least 4 points (absolute MFI-20>13)
Measured: Week 24
chronic fatigue remission
MFI-20 <13
Measured: Week 12
Anxiety evaluation
State-Trait Anxiety Inventory (STAI)Y1 and STAI Y2 values
Measured: week 4, week 12, week 24
Depression evaluation
BECK DEPRESSION INVENTORY (BDI-II) values
Measured: week 4, week 12, week 24
Quality of life
Inflammatory Bowel Disease Questionnaire (IBDQ) values
Measured: week 4, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startOct 2014
- Primary completionMay 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic FatigueStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517151
- Sponsor's protocol ID
- 868
- Acronym
- MICI_2011-01
- Status last verified
- Sep 2015
- First submitted
- 4 Aug 2015
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Iron Therapy in Patients With Chronic Fatigue and IBD
- ClinicalTrials.gov ID
- NCT02517151
- Acronym / sponsor ID
- MICI_2011-01 / 868
- Conditions
- Chronic Fatigue, Inflammatory Bowel Disease
- Keywords
- iron, fatigue, crohn's disease, ulcerative colitis, IBD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose | Experimental | Drug: Ferric carboxymaltose200 mg in normal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24. |
| Placebo | Placebo comparator | Drug: Placebonormal saline (NS) 100 ml administered i.v. at day 0 and then every 4 weeks up to week 24. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric carboxymaltoseAlso: Ferinject | Drug | Ferric carboxymaltose |
| PlaceboAlso: Normal saline | Drug | Placebo |
Primary outcome
chronic fatigue remission
Time frame: Week 24
Multidimensional fatigue inventory (MFI-20) <13
5 secondary outcomes
Chronic fatigue reduction
Time frame: Week 24
chronic fatigue remission
Time frame: Week 12
Anxiety evaluation
Time frame: week 4, week 12, week 24
Depression evaluation
Time frame: week 4, week 12, week 24
Quality of life
Time frame: week 4, week 12, week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferric carboxymaltose in people with Chronic Fatigue and Inflammatory Bowel Disease, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvio Danese, MD, PhD (+39 02 8224 ext. 5555, IBDclinicaltrials@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic fatigue remission (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2015.