Low dose oral iron for treating anemia in inflammatory bowel disease
A Pilot Study to Assess the Efficacy and Tolerability of Reduced Dose Oral Iron in the Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease Patients.
This study is testing whether a lower dose of oral iron can effectively treat anemia in people with inflammatory bowel disease compared to the standard dose.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Liverpool University Hospitals NHS Foundation Trust Government |
| Locations | 1 site (Liverpool) |
| Trial ID | NCT06321887 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the efficacy and safety of low dose versus standard dose oral iron preparations for treating iron deficiency anemia (IDA) in patients with inflammatory bowel disease (IBD). It aims to address the ongoing debate regarding the optimal method and amount of elemental iron needed for effective treatment. The study will include patients aged 18-80 years diagnosed with Crohn's disease or ulcerative colitis, assessing their hemoglobin levels and iron status. Participants will receive different doses of ferrous fumarate syrup to evaluate treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with a diagnosis of Crohn's disease or ulcerative colitis and specific hemoglobin and ferritin levels.
Not a fit: Patients under 18, those with advanced liver or renal disease, or those with a history of intolerance to oral iron may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a cost-effective oral treatment option for patients with IDA associated with IBD.
How similar studies have performed: Previous studies have shown mixed results regarding the efficacy of oral versus intravenous iron, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Liverpool
- Liverpool University Foundation NHS Trust — Liverpool, United Kingdom (Recruiting)
Study contacts
- Principal investigator: T Conley — Liverpool University Foundation NHS Trust
- Study coordinator: S Subramanian
- Email: RGT@liverpoolft.nhs.uk
- Phone: 01517062000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.