Intravenous iron for the treatment of fatigue in nonanemic, premenopausal women with low serum ferritin concentration.

Abstract

This is the first study to investigate the efficacy of intravenous iron in treating fatigue in nonanemic patients with low serum ferritin concentration. In a randomized, double-blinded, placebo-controlled study, 90 premenopausal women presenting with fatigue, serum ferritin ≤ 50 ng/mL, and hemoglobin ≥ 120 g/L were randomized to receive either 800 mg of intravenous iron (III)-hydroxide sucrose or intravenous placebo. Fatigue and serum iron status were assessed at baseline and after 6 and 12 weeks. Median fatigue at baseline was 4.5 (on a 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 = .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 = .005), and 82% of iron-treated compared with 47% of placebo-treated patients reported improved fatigue (P = .03). Drug-associated adverse events were observed in 21% of iron-treated patients and in 7% of placebo-treated patients (P = .05); none of these events was serious. Intravenous administration of iron improved fatigue in iron-deficient, nonanemic 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) as ISRCTN78430425.

• Authors: Pierre-Alexandre Krayenbuehl, Edouard Battegay, Christian Breymann, Joerg Furrer, Georg Schulthess
• Journal: Blood (Blood) Vol. 118 Issue 12 Pg. 3222-7 (Sep 22 2011) ISSN: 1528-0020 [Electronic] United States
• PMID: 21705493 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Ferric Compounds
• Placebos
• Sucrose
• Ferritins
• Iron
• Ferric Oxide, Saccharated
• Glucaric Acid

Topics

• Adult
• Double-Blind Method
• Fatigue (blood, drug therapy, physiopathology)
• Female
• Ferric Compounds (administration & dosage, adverse effects, therapeutic use)
• Ferric Oxide, Saccharated
• Ferritins (blood, deficiency)
• Glucaric Acid
• Humans
• Infusions, Intravenous
• Iron (blood)
• Iron Deficiencies
• Patient Selection
• Placebos (administration & dosage)
• Premenopause (blood)
• Research Design
• Sucrose (administration & dosage, adverse effects, therapeutic use)