The effectiveness and tolerability of GlobiFer (haem iron) tablets compared to ferrous sulphate tablets in inflammatory bowel disease: a randomised-controlled trial.

Phase 1

• Conditions: Anaemia in inflammatory bowel disease; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2008-004277-17-GB
• Lead Sponsor: GlobiFer International bvba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Patients with established inactive or mild to moderately active IBD. This is defined for patients with Crohn’s disease as CDAI=220. For patients with ulcerative colitis a Simple Clinical Colitis Activity Index score of =8 defines inactive or mild-moderately active disease [Walmsley, 1998].
Patients with a haemoglobin level at least 1g/dl below the sex specific lowest normal value (i.e. 13g/dl for men and 12g/dl for women; and either mean cell volume (MCV) = 80 fl or ferritin =100 ?g/l or transferrin saturation <20% will be considered as having iron deficiency anaemia and offered iron intervention.

All patients will be kept on their existing treatment for inflammatory bowel disease.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with severe disease activity (defined as CDAI>220 for Crohn’s disease and CAI>8 for Ulcerative colitis) will be excluded. Patients with a history of intolerance of oral iron supplements will be excluded. Patients who have religious or other objections to the ingestion of bovine/animal products will not be recruited. Patients who decline to provide informed consent will also be excluded as will patients with decompensated liver cirrhosis, severe renal disease, severe psychiatric disorder, pregnancy or lactation or haemoglobinopathies. In addition, patients with severe symptomatic anaemia (i.e. shortness of breath, angina, heart failure, dyspnoea) will be excluded and receive treatment according to normal clinical practice (i.e. i.v. iron or blood transfusion). Patients with haemoglobin <7 will be excluded from oral iron therapy. Patients with abnormal low serum folate (<4µg/l) or vitamin B12 (<200ng/l) will be excluded. Patients with known malignancy will be excluded. Patients on current oral or intravenous iron supplementation will be excluded as will those who have had iron supplementation within the last 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified