This is the first study to investigate the efficacy of intravenous iron in treating fatigue in non-anaemic patients with low serum ferritin concentration. In a randomised, double-blinded, placebo-controlled study, 90 premenopausal women presenting with fatigue, serum ferritin ≤50 ng/mL, and haemoglobin ≥120 g/L were randomised to receive either 800 mg intravenous iron (III)-hydroxide sucrose or intravenous placebo. Fatigue and serum iron status were assessed at baseline, after 6 and 12 weeks. Median fatigue at baseline was 4.5 (0 10 scale). Fatigue decreased during the initial 6 weeks by 1.1 in the iron group compared with 0.7 in the placebo group (p=0.07). Efficacy of iron was bound to depleted iron stores: In patients with baseline serum ferritin ≤15 ng/mL, fatigue decreased by 1.8 in the iron group compared with 0.4 in the placebo group (p=0.005), and 82% of iron-treated vs. 47% of placebo-treated patients reported improved fatigue (p=0.03). Drug associated adverse events were observed in 21% of iron-treated patients and 7% of placebo-treated patients (p=0.05), none of these events were serious. Intravenous administration of iron improved fatigue in iron-deficient, non-anaemic women with a good safety and tolerability profile. The efficacy of intravenous iron was bound to a serum ferritin concentration ≤15 ng/mL. This study was registered at the International Standard Randomized Controlled Trial Number Register (www.isrctn.org) with the number ISRCTN78430425.
- Submitted April 21, 2011.
- Accepted June 12, 2011.
- Copyright © 2005 American Society of Hematology