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

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Clinico Humanitas
• Treatments: Ferric Compounds

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)