Anaemia in inflammatory bowel disease
Conditions
Interventions
Trade Name: Actavis FERROUS SULPHATE TABLETS BP 200mg
Product Name: Ferrous sulphate with 65 mg iron++ per tablet
Pharmaceutical Form: Tablet
INN or Pro
Sponsors
GlobiFer International bvba
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Treatment with Globifer Forte leads to better haemoglobin response compared to ferrous sulphate over 12 weeks; Secondary Objective: I) The clinical effect of Globifer Forte is sustained over 24 weeks II) Globifer Forte is better tolerated than ferrous sulphate III) Globifer Forte is associated with fewer side effects and better adherence than ferrous sulphate IV) Iron supplementation (Haem or non-haem) exacerbates inflammatory bowel disease V) Globifer Forte causes a faster resolution of anaemia compared to ferrous sulphate VI) Globifer Forte has a different effect on the colonic microbiota of patients with IBD compared to ferrous sulphate. ;Primary end point(s): Proportion of patients in each of the patient groups who achieve a 1g/dl increase in haemoglobin over baseline at 12 weeks.;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: see E.5.2; Secondary end point(s): Clinical assessment: At each visit the following will be measured in accordance with the Schedule of Assessments: FBC, serum ferritin, transferrin saturation, CRP, ESR, disease activity (CDAI or Simple Clinical Colitis Activity index) and QOL (IBDQ). A 10 point visual analogue scale will be used to assess fatigue. Patients will be asked to provide a stool sample at baseline, 12 weeks and 24 weeks. This will be frozen for later analysis of the microbiota. Safety of treatment: Symptoms and side effects will be assessed using a weekly diary card for the duration of the active treatment and the number of serious side effects will be recorded i.e. death, gastrointestinal side effects, increased disease activity. Adverse events will be recorded from the first intake of the study drug and serious adverse events will be followed up for 30 days after the last intake of study drug. | — |
Countries
United Kingdom
Outcome results
None listed