EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD

Launched by LIVERPOOL UNIVERSITY HOSPITALS NHS FOUNDATION TRUST · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "EffiCacy and sAfEty of Low doSe orAl iRon for Anaemia in IBD," is studying how effective and safe low-dose oral iron supplements are for treating iron deficiency anemia (IDA) in patients with inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis. Iron deficiency anemia is a common issue for people with IBD, but there is still debate about how much iron is needed for it to work well and the best way to take it. The trial will compare low-dose and standard-dose iron supplements to see which works better for patients in different stages of their disease.

To participate in this study, individuals must be between the ages of 18 and 80 and have been diagnosed with Crohn's disease or ulcerative colitis. Participants should have specific blood test results indicating anemia and must be willing to give their consent to join. Throughout the trial, participants will receive either low-dose or standard-dose iron supplements and will be monitored for effectiveness and any side effects. It’s important to note that individuals with certain health conditions, such as advanced liver or kidney disease, or those who have had recent blood transfusions or iron infusions, cannot participate. This study aims to help improve the understanding of how to treat anemia effectively in patients with IBD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient is willing to participate in the study and has signed the informed consent.
• • Patients aged 18-80 years.
• • Patients diagnosed with Crohn's disease or ulcerative colitis diagnosed by conventional clinical, radiological and histological criteria.
• • Remission or active disease.
• • Haemoglobin level 7-13 g/dL men, 7-12 g/dL women and ferritin \<30, normal B12 and folate (or ferritin \<100 but iron sats \<16 in the presence of inflammation defined as CRP\>5mg/L, faecal calprotectin\>250 microgram/g and presence of endoscopic inflammation).
• Exclusion Criteria:
• • Patients under 18 or unable to give informed consent.
• • Patients with advanced liver disease.
• • Patients with advanced renal disease with eGFR\<45ml/min
• • Previous intolerance to even low doses of oral iron
• • Patients with severe cardiovascular disease defined as previous unstable angina and or previous MI without intervention.
• • Participation in other trials in the last 3 months.
• • Serious inter-current infection or other clinically important active disease (including renal and hepatic disease) and recently diagnosed gastrointestinal tract cancers
• • Pregnant, post-partum (\<3months) or breast feeding females
• • Erythropoietin therapy.
• • Recent blood transfusion within 30 days.
• • Recent iron infusion within 30 days.