A Trial of Iron Replacement in Patients With Iron Deficiency.
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|ClinicalTrials.gov Identifier: NCT01067547|
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : April 29, 2015
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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.
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Inflammatory Bowel Disease||Drug: Iron Sucrose. Drug: Iron sucrose||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomised Controlled Trial Comparing the Efficacy of Intravenous Iron Sucrose and Oral Iron Sulfate in Patients With Iron Deficiency.|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||May 2014|
Experimental: iron sulfate
Oral iron sulfate 300mg tid
Drug: Iron Sucrose.
The total dose of iron sucrose given will be individualised by calculating their iron deficit.
Other Name: Iron sucrose is been marketed in Canada as Venofer.
Active Comparator: intravenous iron sulfate
intravenous iron sulfate 300 mg
Drug: Iron sucrose
300mg of iron sucrose is given intravenously. Three infusions, each one week apart is given to patients with iron deficiency without anemia. For those patient with anemia, four infusions would be given.
Other Name: Venofer
- Improvement of iron saturation at week 8. [ Time Frame: month 0,2,3. ]
- To describe the change in the faecal bacteria composition pre and post iron replacement. [ Time Frame: Three measurments - at month 0,3. ]
- To describe the changes in ferritin, haemoglobin, Hepcidin,IBDQ, Modified HBI and partial MAYO score in patients before and after iron replacement. [ Time Frame: month 0,2,3 ]
- To describe the changes in the colonic mucosal endoplasmic reticulum as an indicator of oxidative stress. [ Time Frame: month 0 and 3. ]
- To describe the changes in urinary metabolomics from iron replacement. [ Time Frame: month 0,3. ]
- Compare the health economics of intravenous versus oral iron replacement. [ Time Frame: End of study. ]
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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%
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067547
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2X8|
|Principal Investigator:||Richard N Fedorak, MD||University of Alberta|
|Responsible Party:||Richard Fedorak, Professor, Gastroenterology, University of Alberta|
|Other Study ID Numbers:||
UA 2009 TL
|First Posted:||February 11, 2010 Key Record Dates|
|Last Update Posted:||April 29, 2015|
|Last Verified:||April 2015|
Inflammatory Bowel Disease
Inflammatory Bowel Diseases
Digestive System Diseases
Iron Metabolism Disorders
Ferric Oxide, Saccharated
Physiological Effects of Drugs