Iron therapy in IBD patients with normal levels of haemoglobin and chronic fatigue

Conditions: patients with IBD and chronic fatigue
MedDRA version: 14.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-002122-43-IT

Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Man and women, 18 years of age or older. - Female subjects must utilize a highly effective method of birth control throughout the study. - At least 12-month history of IBD. - Inactive Crohn’s disease or Ulcerative colitis (HB: <5, Mayo Clinical Score: = 2) since at least 6 months - Chronic fatigue symptoms (Mfi-20 > 13). - Concurrent stable doses of 5-aminosalicylate, azathioprine, methotrexate or anti TNFa. - Iron deficiency: ferritin< 100 ng/ml or ferritin 100-300 ng/ml when transferring saturation (TSAT) < 20%.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Known hypersensitivity to iron sucrose or to its excipients. - Pregnancy: women with childbearing potential must not become pregnant during the study. - Clinically active IBD and /or C-reactive protein >2.5. - Comorbidity possibly resulting in (additional) fatigue (e.g., kidney or adrenal insufficiency, autoimmune diseases, malignancy, depression, a recent viral infection, or psychotrauma psychic diseases, included depression. - Anaemia (Hb:< 12.5 in male and < 11.5 in female

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: chronic fatigue remission (MFI-20 <13);Secondary Objective: Clinical response, defined as decrease in MFI-20 of at least 4 points, but with a score > 13;Primary end point(s): chronic fatigue remission;Timepoint(s) of evaluation of this end point: 24 weeks

Secondary Outcome Measures