A Trial of Iron Replacement in Patients With Iron Deficiency.
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
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.