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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000586314

Acronym

IRonIBDH

Enrollment

Registered

2017-04-26

Start date

2017-05-08

Completion date

2018-05-08

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

17 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. 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) 2. Age greater than 16 years old 3. Ferritin equal or less than 30 ug/L 4. Haemoglobin equal or greater than 130g/L male and equal or greater than 120g/L in females

Exclusion criteria

1. Macrocytosis indicated by increased mean corpuscular volume (MCV) in the absence of thiopurine use 2. Pregnant or actively trying to conceive 3. Previous oral or IV iron intolerant/allergic 4. Haemoglobinopathy 5. Folate/B12 deficiency 6. Iron overload 7. Current corticosteroid use or change in IBD medications within the last 3 month

Outcome results