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

Ulcerative Colitis Clinical Trial

Official title:

Treatment of Iron Deficiency Anaemia in Adults and Adolescents With Inflammatory Bowel Disease Using Ferrous Sulphate: Tolerance and Effects on Haemoglobin, Mood, Quality of Life and Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991314
• Other study ID #: 2010-023797-39
• Status: Completed
• Phase: Phase 4
• First received: November 18, 2013
• Last updated: November 30, 2015
• Start date: December 2011
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 80 Years

Eligibility

Inclusion Criteria:

Patients with proven iron deficiency anaemia on World Health Organisation (WHO)criteria Patients aged 13 - 18 will be considered adolescents, and aged >18 as adults.

Exclusion Criteria:

Anaemia caused by B12 or folate deficiency, or secondary to drugs used to treat IBD; haemoglobinopathies or myelodysplasia; severe cardiopulmonary, hepatic or renal disease; severe cardiopulmonary, hepatic or renal disease; pregnancy and breast feeding females.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Drug:
• Ferrous sulphate
200mg tablets.

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean increase in haemoglobin concentration.		6 weeks	No
Secondary	Tolerance of oral iron		6 weeks	Yes
Secondary	Change in disease activity (stool calprotectin)	Faecal calprotectin	6 weeks	Yes
Secondary	Change in quality of life score	Inflammatory Bowel Disease Questionnaire (IBDQ score)	6 weeks	No
Secondary	Changes in mood	Hospital Anxiety and Depression Score (HADS)	6 weeks	No
Secondary	Changes in fatigue	Multifactorial Fatigue Inventory (MFI)	6 weeks	No
Secondary	Changes in stress levels	Perceived Stress Questionnaire (PSQ)	6 weeks	No