drugset / Trial / NCT01374776

Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance in Premenopausal Women

NCT01374776

Phase 4 Completed 24 enrolled University of Zurich
RandomizedParallel-groupDouble-blindTreatment

Summary

Effect of intravenous iron substitution (iron carboxymaltose (Ferinject®), total dose 15 mg/ kg (maximal dose: 1000mg) in 250 ml 0.9 % NaCl; intravenous infusion in 20 min)in non-anemic premenopausal women with iron deficiency on Primary objective: \- Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle) Secondary objectives: * Maximal oxygen uptake during a graded cycling exercise test and time to exhaustion at submaximal power during a constant-load cycling exercise test * Plantarflexor muscle fatiguability as assessed by isokinetic dynamometry * Trial with medicinal product

Timeline

Start
2013-02
Primary completion
2014-09
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 15 mg/kg Intravenous

Indications