EUCTR2018-002982-20-GB
Active, not recruiting
Phase 1
A Pilot Study to assess the efficacy and safety of reduced dose oral iron in the treatment of iron deficiency anaemia in inflammatory bowel disease patients - Efficacy and safety of low dose oral iron for anaemia in IBD (CAESAR)
ConditionsIron deficiency anaemia in inflammatory bowel diseaseMedDRA version: 20.0Level: LLTClassification code 10002062Term: Anaemia iron deficiencySystem Organ Class: 100000004851MedDRA version: 20.1Level: PTClassification code 10021972Term: Inflammatory bowel diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Iron deficiency anaemia in inflammatory bowel disease
- Sponsor
- Royal Liverpool University Hospital
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(i)Patient is willing to participate in the study and has signed the informed consent
- •(ii)Patients aged 18\-80 with Crohn’s disease or ulcerative colitis diagnosed by conventional clinical, radiological and histological criteria.
- •(ii)Haemoglobin level 7\-13 g/dL men, 7\-12 g/dL women and evidence of iron deficiency as defined by ferritin \<100 ug/l, normal B12 and folate, ferritin \<200 ug/l but iron saturation \<18% in the presence of anaemia and raised inflammtory markers
- •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 20
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 10
Exclusion Criteria
- •(i)Patients under 18 or unable to give informed consent.
- •(ii)Patients with advanced liver disease.
- •(iii)Patients with advanced renal disease.
- •(iv)Previous intolerance of oral iron.
- •(v)Patients with severe cardiovascular disease defined as previous unstable angina and or previous MI without intervention.
- •(vi)Participation in other trials in the last 3 months.
- •(vii)Serious inter\-current infection or other clinically important active disease (including renal and hepatic disease)
- •(viii)Pregnant, post partum (\<3months) or breast feeding females
- •(ix)Erythropoetin therapy.
- •(x)Recent blood transfusion within 30 days.
Outcomes
Primary Outcomes
Not specified
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