A Trial of Iron Replacement in Patients With Iron Deficiency.

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or intravenous route in Inflammatory Bowel Disease patients.

Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD) and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor quality of life, poor concentration span and low energy level. Blood transfusion may improve symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born infection transmission. Moreover, packed cells are scarce resource therefore its use needs to be carefully prioritized. Oral iron supplement has been widely used and it can be purchased over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly tolerated with side effects include altered bowel habit, nausea and darken stools, making it difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has been supported by its post marketing surveillance. Limitations with intravenous iron replacement include the need for medical supervision in the setting of limited healthcare resources; the need for patients to take multiple days off work and the cost of Venofer®. Currently it is uncertain which method of iron replacement is better. The purpose of this study is to compare the efficacy and the cost of oral and intravenous iron replacement in the setting of iron deficiency anaemia.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Richard Fedorak
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

IBD group:

• Inflammatory Bowel Disease diagnosed by standard clinical, endoscopic and histological criteria

• Iron deficiency: Ferritin <12 if normal CRP or Ferritin <100 if elevated CRP AND/OR iron saturation < 16%

• stable dose of thiopurine or methotrexate for 1 month

Control group:

• Iron deficiency without IBD/ Coeliac disease/ haematological malignancy

• iron deficiency: Ferritin <12 if normal CRP or CRP <100 if elevated CRP AND/OR iron saturation < 16%

Exclusion Criteria:

Patients:

• with severe IBD who is likely to need hospitalization within 4 weeks of enrollment

• with untreated concurrent Vitamin B12 or folate deficiency at baseline

• with Coeliac disease

• pregnant and/or breast feeding