Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

A Trial of Iron Replacement in Patients With Iron Deficiency.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01067547
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : April 29, 2015
Information provided by (Responsible Party):
Richard Fedorak, University of Alberta

Brief 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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Inflammatory Bowel Disease Drug: Iron Sucrose. Drug: Iron sucrose Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improvement of iron saturation at week 8. [ Time Frame: month 0,2,3. ]

Secondary Outcome Measures :
  1. To describe the change in the faecal bacteria composition pre and post iron replacement. [ Time Frame: Three measurments - at month 0,3. ]
  2. 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 ]
  3. To describe the changes in the colonic mucosal endoplasmic reticulum as an indicator of oxidative stress. [ Time Frame: month 0 and 3. ]
  4. To describe the changes in urinary metabolomics from iron replacement. [ Time Frame: month 0,3. ]
  5. Compare the health economics of intravenous versus oral iron replacement. [ Time Frame: End of study. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01067547

Layout table for location information
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2X8
Sponsors and Collaborators
Richard Fedorak
Layout table for investigator information
Principal Investigator: Richard N Fedorak, MD University of Alberta
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Richard Fedorak, Professor, Gastroenterology, University of Alberta Identifier: NCT01067547    
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
Keywords provided by Richard Fedorak, University of Alberta:
Iron deficiency
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative colitis
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Inflammatory Bowel Diseases
Anemia, Iron-Deficiency
Iron Deficiencies
Gastrointestinal Diseases
Digestive System Diseases
Iron Metabolism Disorders
Metabolic Diseases
Anemia, Hypochromic
Hematologic Diseases
Ferric Oxide, Saccharated
Trace Elements
Physiological Effects of Drugs