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Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease With Ferrous Sulphate

NCT01991314 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-05-09

Study results available
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Summary

Iron deficiency anaemia is common in inflammatory bowel disease (IBD), affecting at least 20% patients at any one time. Hepcidin, a recently described anti-microbial peptide synthesized by the liver, is a key regulator of iron homeostasis. It interferes with absorption of iron into enterocytes, macrophages and hepatocytes by binding to ferroportin. Hepcidin levels rise when total body iron levels rise and protect against iron overload; conversely, in iron deficiency, levels are low. Hepcidin levels also rise under the influence of interleukins (IL)-6 and -1, a factor likely to contribute to iron deficient erythropoesis in active IBD. Whether hepcidin levels predict resistance to oral iron therapy in IBD is unknown, though it may impair its immediate oral absorption. Adult IBD patients who are anaemic report quality of life and fatigue scores comparable to those seen in malignancy.

IBD diagnosed in adolescence interferes with growth, education and employment as well as psychosocial and sexual development. Not surprisingly, adolescents with IBD have a high prevalence of psychological distress, particular depression. Limited historical, and our own data suggest that children and adolescents with IBD are more anaemic than adults, and less often treated with oral iron. What is not clear is whether the apparent under-utilisation of oral iron in paediatric care is because of a perceived lack of benefit or doctors' concerns about possible side effects including worsening disease activity.

To address these questions, the investigators propose a comparative study of 6 weeks of oral iron supplementation in adolescents and adults with iron deficiency anaemia in IBD. Patients will be given oral iron supplementation. Before and after iron therapy, the investigators shall assess haemoglobin concentrations; IBD activity; quality of life (QOL), perceived stress, mood and fatigue; iron metabolism, including serum hepcidin.

Conditions

Interventions

DRUG

Ferrous sulphate

200mg tablets.

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • David S Rampton, DPhil, FRCP · Queen Mary London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991314 on ClinicalTrials.gov