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

NCT01991314 | Completed Phase 4 Results

• 1 other identifier: 2010-023797-39
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Ulcerative Colitis; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Mean Change in Haemoglobin Concentration.

  Change in serum Hb concentration in g/dl after 6 weeks of oral iron

  Baseline (0 weeks) and end of trial (6 weeks)

Secondary Outcomes (6)

• Intolerance of Oral Iron

  Baseline (0 weeks) to end of trial (6 weeks)

• Change in Disease Activity (Stool Calprotectin)

  Baseline (0 weeks) and end of trial (6 weeks)

• Change in Quality of Life Score

  Baseline (0 weeks) to end (6 weeks)

• Changes in Anxiety

  Baseline (0 weeks) and end of trial (6 weeks)

• Changes in Fatigue

  Baseline (0 weeks) and end of trial (6 weeks)

Study Arms (1)

Ferrous sulphate

EXPERIMENTAL

Ferrous sulphate 200mg twice daily for 6 weeks

Drug: Ferrous sulphate

Interventions

Ferrous sulphate DRUG

200mg tablets.

Ferrous sulphate

Eligibility Criteria

• Age: 13 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts Health NHS Trust

London, London, E11 BB, United Kingdom

Location

Related Publications (1)

• Rampton DS, Goodhand JR, Joshi NM, Karim AB, Koodun Y, Barakat FM, Macken L, Ward DG, Iqbal TH, Epstein J, Fell JM, Sanderson IR. Oral Iron Treatment Response and Predictors in Anaemic Adolescents and Adults with IBD: A Prospective Controlled Open-Label Trial. J Crohns Colitis. 2017 Jun 1;11(6):706-715. doi: 10.1093/ecco-jcc/jjw208.

  PMID: 27932449 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

Findings may not be generalizable. Trial not blinded. We studied patients who had tolerated oral iron before or were naïve to it. Only half of patients returned tablet containers for counting. Questionnaires used not validated for young people.

Results Point of Contact

• Title: Prof David Rampton
• Organization: Barts Health NHS Trust

d.rampton@qmul.ac.uk

+442035943500

Study Officials

• David S Rampton, DPhil, FRCP

  Queen Mary London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: This was an open label trial
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 9, 2017
• Results First Posted: March 7, 2017

Record last verified: 2015-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)