Not Yet RecruitingPhase 4ACTRN12617000586314

A study comparing the effect of intravenous and oral iron supplementation on the quality of life of inflammatory bowel disease patients with iron deficiency without anaemia

A Prospective, Randomized, Multicentre Study to Evaluate the Effect of Intravenous Iron Infusion Compared with Oral Iron Supplementation on the Quality of Life in Inflammatory Bowel Disease Patients with Non-Anaemic Hypoferritinaemia

Sponsor

Dr Stephen Inns

Enrollment

58 participants

Start Date

May 8, 2017

Study Type

Interventional

Conditions

Inflammatory Bowel Disease Hypoferritinaemia

Summary

The study is to compare the effect of Intravenous Iron Infusion Compared with Oral Iron Supplementation on the Quality of Life in Inflammatory Bowel Disease (IBD) Patients with low iron level without anaemia. The hypothesis is intravenous iron is superior to oral supplementation in improving the quality of life and fatigue of IBD patients. Patients eligible will be randomly assigned to receive either intravenous iron or oral iron for 6 weeks. Questionnaires on quality of life and fatigue will be completed by all participants at the start and 6 weeks after given iron supplementation. The change in the quality of life and fatigue scores will be assessed at the end of the study.

Eligibility

Sex: Both males and femalesMin Age: 17 YearssMax Age: 80 Yearss

Inclusion Criteria6

IBD diagnosed for at least 3 months and disease in remission for at least 3 months indicative by:
HBAI less or equal to 3 in Crohn’s disease (CD), SCCAI less than or equal to 3 in ulcerative (UC) patients AND
normal C-reactive protein (< 5)
Age greater than 16 years old
Ferritin equal or less than 30 ug/L
Haemoglobin equal or greater than 130g/L male and equal or greater than 120g/L in females

Exclusion Criteria7

Macrocytosis indicated by increased mean corpuscular volume (MCV) in the absence of thiopurine use
Pregnant or actively trying to conceive
Previous oral or IV iron intolerant/allergic
Haemoglobinopathy
Folate/B12 deficiency
Iron overload
Current corticosteroid use or change in IBD medications within the last 3 month

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Interventions

History taking, physical exam, blood test, stool test are involved in patient selection to ensure suitability by qualified gastroenterologists or gastroenterology trainees. Patient information sheet is provided. Research Nurse specialist or above mentioned clinicians will go through consent form with eligible patients. Consented inflammatory bowel disease patients in remission with low ferritin level without anaemia will then be randomly assigned patients to either treatment with intravenous (Arm 1) or oral iron (Arm 2). All patients will complete two questionnaires at baseline, one on quality of life and the other on fatigue. Arm 1: one off visit for administration of intravenous Ferric Carboxymaltose (Ferrinject) 1000mg Arm 2: oral ferrous sulfate 1x 325mg tablet once dailyi for 6 weeks. Tablets will be counted at the end of study to assess adherence. At the end of six weeks, all patients will be seen by clinicians to assess inflammatory bowel disease activity through history taking, physical exam, blood test. The same questionnaires on quality of life and fatigues will be completed at end of intervention.