Trial Details
Not RecruitingBasic Information
| Clinical ID | c3138 |
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| Identifier | ACTRN12613000751774 |
| Trial Title | 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. |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | Paediatric Inflammatory Bowel Disease;Iron deficiency anaemia__;Iron deficiency without anaemia; Paediatric Inflammatory Bowel Disease Iron deficiency anaemia Iron deficiency without anaemia;Oral and Gastrointestinal - Inflammatory bowel disease |
| Interventions | In Inflammatory bowel disease patients with iron deficiency, baseline iron status will be obtained, along with quality of life data (using IMPACT III questionnaire) and cognitive function (WISC). A single intravenous iron infusion with Ferric Carboxymaltose (15mg/kg up to a maxmum dose of 500mg, in 100mL N/Saline) will be administered, and 8 weeks following this iron status, quality of life and cognitive function will be obtained, and results compared. If iron deficiency is ongoing, a second infusion of Ferric Carboxymaltose will be administered. |
Participant Information
| Sponsor | Gastroenterology Department, Royal Children's Hospital - Brisbane |
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| City | - |
| Country/Region | Australia |
Enrollment Criteria
| Sex Requirement | ALL |
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| Age Requirement | ADULT, CHILD, TEENAGER |
Study Design
| Study Type | Interventional |
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| Phase | PHASE4 |
Time Information
| Start Date | 2025-04-24 |
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| Primary Completion Date | - |
| Completion Date | - |