The treatment of restless legs syndrome with intravenous iron dextran

Christopher J. Earley, Debbie Heckler, Richard P. Allen

Research output: Contribution to journalArticlepeer-review

162 Scopus citations


Background and purpose: To evaluate the safety and efficacy of a single 1000 mg iron infusion in treating Restless Legs Syndrome (RLS). Patients and methods: A single 1000 mg intravenous (IV) [Am J Med Sci 31 (1999) 213] infusion of iron dextran was evaluated in an open-label study. Primary outcomes of efficacy were symptom severity assessed by global rating scale and periodic leg movements in sleep (PLMS) at 2 weeks post-infusion. Secondary outcomes included total sleep time (TST), hours/day of RLS symptoms, and changes in magnetic resonance imaging (MRI)-determined iron concentrations in the substantia nigra. Primary safety measures were reported adverse events and monthly serum ferritin levels. Results: IV iron therapy significantly improved the mean global RLS symptom severity, TST, hours with RLS symptoms and PLMS, but on an individual basis failed to produce any response in 3 of the 10 subjects who were fully treated. Brian iron concentrations at 2 weeks post-infusion as determined by MRI were increased in the substantia nigra and prefrontal cortex. Serum ferritin levels showed a greater than predicted rapid linear decrease. Side effects were mild, except in one subject who developed an acute allergic reaction. Conclusions: The results in this study provide valuable information for future studies, but the efficacy and safety of IV iron treatment for RLS remain to be established in double-blind studies. The serum ferritin results suggest that greater than expected iron loss occurs after IV iron loading.

Original languageEnglish (US)
Pages (from-to)231-235
Number of pages5
JournalSleep Medicine
Issue number3
StatePublished - May 2004


  • Ferritin
  • Iron
  • Magnetic resonance imaging
  • Periodic leg movement
  • Restless legs syndrome
  • Treatment

ASJC Scopus subject areas

  • Medicine(all)


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