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)

Royal Liverpool University Hospital0 个研究点目标入组 30 人开始时间: 2019年12月5日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•(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

•(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.
•(xi)Recent iron infusion within 30 days.

发起方