Inflammatory Bowel Disease Clinical Trial
— MICI_2011-01Official 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.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | December 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 (TNFa) 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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | IBD Center | Rozzano | MI |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | chronic fatigue remission | Multidimensional fatigue inventory (MFI-20) <13 | Week 24 | No |
Secondary | Chronic fatigue reduction | MFI-20 reduction of at least 4 points (absolute MFI-20>13) | Week 24 | No |
Secondary | chronic fatigue remission | MFI-20 <13 | Week 12 | No |
Secondary | Anxiety evaluation | State-Trait Anxiety Inventory (STAI)Y1 and STAI Y2 values | week 4, week 12, week 24 | No |
Secondary | Depression evaluation | BECK DEPRESSION INVENTORY (BDI-II) values | week 4, week 12, week 24 | No |
Secondary | Quality of life | Inflammatory Bowel Disease Questionnaire (IBDQ) values | week 4, week 12, week 24 | No |
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