Efficacy of oral iron in patients with restless legs syndrome and a low-normal ferritin: A randomized, double-blind, placebo-controlled study

James Wang, Brian O'Reilly, Ramesh Venkataraman, Vincent Mysliwiec, Angela Mysliwiec

Research output: Contribution to journalArticlepeer-review

162 Scopus citations

Abstract

Background and Purpose: Restless Legs Syndrome (RLS) is a primary disorder of sensation that affects sleep and has been associated with iron deficiency. The purpose of this study was to determine if symptomatic RLS patients with low-normal serum ferritin levels benefit from oral iron replacement. Patients and Methods: This was a randomized, placebo-controlled, double-blinded study. Eligible patients were randomized to oral iron therapy vs. appearance-matched placebo and followed over a 12 week period. Results: Baseline International Restless Leg Scale (IRLS) scores for the treatment (24.8 ± 5.72) and placebo (23.0 ± 5.03) groups were similar. Baseline ferritin levels for the treatment (40.6 ± 15.3 ng/ml) and placebo (36.7 ± 20.8 ng/ml) groups were also similar. After 12 weeks, IRLS scores decreased more in the treatment arm (10.3 ± 7.40) than in the placebo arm (1.14 ± 5.64), (p = 0.01). Ferritin levels increased more in the treatment arm (25.1 ± 20.3 ng/ml) than in the placebo arm (7.5 ± 13.7 ng/ml), (p = 0.04). We observed a nonsignificant trend toward improved quality of life in the treated patients, (p = 0.07). Conclusions: This is the first double-blinded, placebo-controlled study to demonstrate statistically significant improvement in RLS symptoms using oral iron therapy in patients with low-normal ferritin. The findings from this study suggest that additional larger randomized placebo-controlled trials of iron as treatment for patients with low-normal ferritin are warranted.

Original languageEnglish (US)
Pages (from-to)973-975
Number of pages3
JournalSleep Medicine
Volume10
Issue number9
DOIs
StatePublished - Oct 2009
Externally publishedYes

Keywords

  • Clinical trial
  • Ferritin
  • International Restless Legs Scale (IRLS)
  • Iron deficiency
  • Iron sulfate
  • Restless legs syndrome

ASJC Scopus subject areas

  • Medicine(all)

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