IV Iron Sucrose vs Oral FeSO4 in Treating IDA in Pediatric IBD

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of intravenous iron sucrose in comparison to oral ferrous sulfate in improving iron deficiency anemia in children with inflammatory bowel disease.

Clinical Trial Description

Iron deficiency anemia (IDA) is very common among children with inflammatory bowel disease. Causes in this population are multi-factorial, including decreased absorption due to intestinal disease, increased losses due to bleeding from the gastrointestinal (GI) tract, and poor nutrition. IDA can cause significant impaired physical activity and is associated with developmental and cognitive abnormalities in children and adolescents. Oral ferrous sulfate has been traditionally used to treat iron deficiency anemia, but this is associated with limitations. Studies have shown that only a part of the oral iron is absorbed and the non-absorbed iron salts can be toxic to the intestinal mucosa, and was also theorized to be capable of activating the Inflammatory Bowel Disease (IBD). Use of intravenous iron sucrose has been used in other populations with iron deficiency anemia such as those with chronic kidney disease and children with significant blood loss after spinal surgery. The aim of this study is to determine the safety and efficacy of intravenous iron sucrose in improving iron deficiency anemia in children with inflammatory bowel disease (in comparison to oral ferrous sulfate). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01438372
Study type	Interventional
Source	Wayne State University
Contact
Status	Withdrawn
Phase	Phase 2
Start date	November 2011
Completion date	March 2012

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