TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE

TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023797-39-GB

Enrollment

Registered

2011-07-16

Start date

2011-08-12

Completion date

Unknown

Last updated

2019-06-30

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

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

Interventions

Trade Name: Iron sulphate 200mg coated tablets Product Name: Ferrous sulphate Product Code: Ferrous sulphate Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 0

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Is there a difference in the response to treatment with iron supplementation in adolescents and adults in IBD? 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. ; Secondary Objective: 1. Oral iron does not adversely affect IBD symptoms or objective markers of inflammation. 2. A raised serum hepcidin level will reduce the response to iron therapy. 3. Oral iron improves health-related QOL, perceived stress, mood disorders and fatigue. 4. Treatment of anaemia restores ANS homeostasis and improves exercise tolerance in IBD. ;Primary end point(s): Primary outcome: Mean increase in haemoglobin after 6 weeks of treatment.	—

Measure

Time frame

Main Objective: Is there a difference in the response to treatment with iron supplementation in adolescents and adults in IBD? 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. ; Secondary Objective: 1. Oral iron does not adversely affect IBD symptoms or objective markers of inflammation. 2. A raised serum hepcidin level will reduce the response to iron therapy. 3. Oral iron improves health-related QOL, perceived stress, mood disorders and fatigue. 4. Treatment of anaemia restores ANS homeostasis and improves exercise tolerance in IBD. ;Primary end point(s): Primary outcome: Mean increase in haemoglobin after 6 weeks of treatment.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026