A Trial of Iron Replacement in Patients With Iron Deficiency.

NCT01067547 | Completed Phase 4

• 1 other identifier: UA 2009 TL
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency; Inflammatory Bowel Disease

Keywords

Iron deficiency; Inflammatory Bowel Disease; Crohn's Disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Improvement of iron saturation at week 8.

  month 0,2,3.

Secondary Outcomes (5)

• To describe the change in the faecal bacteria composition pre and post iron replacement.

  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.

  month 0,2,3

• To describe the changes in the colonic mucosal endoplasmic reticulum as an indicator of oxidative stress.

  month 0 and 3.

• To describe the changes in urinary metabolomics from iron replacement.

  month 0,3.

• Compare the health economics of intravenous versus oral iron replacement.

  End of study.

Study Arms (2)

iron sulfate

EXPERIMENTAL

Oral iron sulfate 300mg tid

Drug: Iron Sucrose.

intravenous iron sulfate

ACTIVE COMPARATOR

intravenous iron sulfate 300 mg

Drug: Iron sucrose

Interventions

Iron sucrose DRUG

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.

Also known as: Venofer

intravenous iron sulfate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Richard Fedorak: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2X8, Canada

Location

Related Publications (1)

• Lee T, Clavel T, Smirnov K, Schmidt A, Lagkouvardos I, Walker A, Lucio M, Michalke B, Schmitt-Kopplin P, Fedorak R, Haller D. Oral versus intravenous iron replacement therapy distinctly alters the gut microbiota and metabolome in patients with IBD. Gut. 2017 May;66(5):863-871. doi: 10.1136/gutjnl-2015-309940. Epub 2016 Feb 4.

  PMID: 26848182 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Richard N Fedorak, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: February 11, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: April 29, 2015

Record last verified: 2015-04

Locations

CA (1)