In children with inflammatory bowel disease and iron deficiency, does intravenous iron therapy with Ferric Carboxymaltose significantly improve cognitive function, quality of life and iron status.
Phase 4
- Conditions
- Paediatric Inflammatory Bowel DiseaseIron deficiency anaemiaIron deficiency without anaemiaOral and Gastrointestinal - Inflammatory bowel disease
- Registration Number
- ACTRN12613000751774
- Lead Sponsor
- Gastroenterology Department, Royal Children's Hospital - Brisbane
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Paediatric patients with documented inflammatory bowel disease (Crohn's disease or Ulcerative colitis) being treated at the Royal Children's Hospital, with iron deficiency as defined by international criteria (ferritin less than 30, TS less than 16% or ferritin less than 100 with coexisting inflammation)
Exclusion Criteria
Patients will be excluded if:
1 - They have a haemoglobinopathy
2 - They received a blood transfusion in the previous 6 weeks
3 - Patient or family do not give consent for participation in the study
4 - They have advanced liver disease
5 - They have acute severe colitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method