ACTRN12613000751774Not yet recruitingPhase 4
In children with inflammatory bowel disease and iron deficiency, does intravenous iron therapy with Ferric Carboxymaltose signficantly improve cognitive function, quality of life and iron status.
Gastroenterology Department, Royal Children's Hospital - Brisbane0 sites50 target enrollmentStarted: July 5, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 6 Years to 18 Years (—)
- Sex
- All
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
Investigators
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