A Trial of Iron Replacement in Patients With Iron Deficiency.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Alberta.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT01067547
First received: November 12, 2009
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Iron Deficiency
Inflammatory Bowel Disease
Drug: Iron Sucrose.
Drug: Oral iron sulfate - active comparator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Improvement of iron saturation at week 8. [ Time Frame: month 0,2,3. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the change in the faecal bacteria composition pre and post iron replacement. [ Time Frame: Three measurments - at month 0,3. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To describe the changes in the colonic mucosal endoplasmic reticulum as an indicator of oxidative stress. [ Time Frame: month 0 and 3. ] [ Designated as safety issue: Yes ]
  • To describe the changes in urinary metabolomics from iron replacement. [ Time Frame: month 0,3. ] [ Designated as safety issue: No ]
  • Compare the health economics of intravenous versus oral iron replacement. [ Time Frame: End of study. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Drug: Oral iron sulfate - active comparator
    Iron sulfate 300mg PO bid for 3 months.
    Other Name: Iron sulfate is also marketed as Ferrograd.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067547

Contacts
Contact: Richard N Fedorak, MD 1.780.492.8118 richard.fedorak@ualberta.ca
Contact: Thomas W Lee, MBBS 1.780.248.1033 twlee@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Contact: Thomas W Lee, MBBS    1.780.248.1033    twlee@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Richard N Fedorak, MD University of Alberta
  More Information

No publications provided

Responsible Party: Richard N Fedorak, University of Alberta
ClinicalTrials.gov Identifier: NCT01067547     History of Changes
Other Study ID Numbers: UA 2009 TL
Study First Received: November 12, 2009
Last Updated: January 10, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Iron deficiency
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative colitis

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Inflammatory Bowel Diseases
Intestinal Diseases
Anemia
Anemia, Hypochromic
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Ferric oxide, saccharated
Iron
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 20, 2014