drugset / Trial / NCT02541708

IV Ferric Carboxymaltose Compared With Oral Iron in the Treatment of Iron Deficiency Anemia at Delivery in Tanzania

NCT02541708

RandomizedParallel-groupOpen-labelTreatment

Summary

Intravenous iron preparations have been shown to be superior to oral iron and have largely replaced the treatment of anaemia in Northern countries. However, the socio-economic and medical conditions in low resource countries greatly differ from those in northern countries. Patients' different access to medication supply, perception of medication need and compliance as well as the burden of concomitant disease like malaria, soil-transmitted helminths, schistosomiasis, HIV and red blood cells (RBC) genetic disorders may influence effectiveness and safety of iron substitution modality. The aim of the present study is to compare iv iron substitution by ferric carboxymaltose (Ferinject®) to per oral iron substitution in a low resource country

Timeline

Start
2015-09
Primary completion
2018-04
Completion
2018-04

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 20 mg/kg Intravenous
Comparator Ferrous Sulfate Diagnostic / imaging agent 60 mg Oral
Comparator folic acid Other / unclassified 0.25 mg Oral