TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE

Phase 1

• Conditions: Inflammatory bowel disease; MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2010-023797-39-GB
• Lead Sponsor: Barts Health NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-16
• Study Completion: 2015-08-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 88

Inclusion Criteria

Patients with IDA complicating their IBD. Anaemia will be defined by age and sex-adjusted World Health Organisation criteria. Because serum ferritin is an acute phase reactant, patients with iron deficiency will be defined by a transferrin saturation <16%.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

- Patients who cannot read English, as not all of the questionnaires in the study have been validated in Non-English languages.
- Patients who present to the clinic and who are overtly ill requiring admission will also be excluded.
- Patients who are anaemic for a different reason, including folic acid, B12 deficiency, as a result of thiopurine use (pancytopenia), or with co-existent haemaglobinopathies or myelodysplasia.

- Patients under the age of 13 and over the age of 90.

- Patients with severe cardiopulmonary disease, hepatic or renal impairment, pregnancy, alcohol or drug abuse.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Is there a difference in the response to treatment with iron supplementation in adolescents and adults in IBD? <br> <br> We hypothesise that there is no difference in the haematological response to treatment of iron deficiency anaemia with oral iron in adults and adolescents with IBD.<br> <br> ;<br> Secondary Objective: 1.Oral iron does not adversely affect IBD symptoms or objective markers of inflammation.<br> 2.A raised serum hepcidin level will reduce the response to iron therapy.<br> 3.Oral iron improves health-related QOL, perceived stress, mood disorders and fatigue. <br> 4.Treatment of anaemia restores ANS homeostasis and improves exercise tolerance in IBD. <br> ;Primary end point(s): Primary outcome: Mean increase in haemoglobin after 6 weeks of treatment.