title: 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.affiliation: Division of Internal Medicine, University Hospital Zurich, Zurich, Switzerland. pierrea.krayenbuehl@usz.ch
authors.forename: Pierre-Alexandre
authors.initials: PA
authors.lastname: Krayenbuehl
authors.forename: Edouard
authors.initials: E
authors.lastname: Battegay
authors.forename: Christian
authors.initials: C
authors.lastname: Breymann
authors.forename: Joerg
authors.initials: J
authors.lastname: Furrer
authors.forename: Georg
authors.initials: G
authors.lastname: Schulthess
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005221:Fatigue / Q000097:blood / Q000188:drug therapy / Q000503:physiopathology; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077605:Ferric Oxide, Saccharated; D005293:Ferritins / Q000097:blood* / Q000172:deficiency; D005937:Glucaric Acid; D006801:Humans; D007262:Infusions, Intravenous; D007501:Iron / Q000097:blood*; D000090463:Iron Deficiencies; D018579:Patient Selection; D010919:Placebos / Q000008:administration & dosage; D017697:Premenopause / Q000097:blood; D012107:Research Design; D013395:Sucrose / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D005290:Ferric Compounds; D010919:Placebos; D013395:Sucrose; D005293:Ferritins; D007501:Iron; D000077605:Ferric Oxide, Saccharated; D005937:Glucaric Acid