Evaluation of a Single Dose of Ferric Carboxymaltose in Fatigued, Iron-Deficient Women – PREFER a Randomized, Placebo-Controlled Study
Open accessAbstract
BACKGROUND: Unexplained fatigue is often left untreated or treated with antidepressants. This randomized, placebo-controlled, single-blinded study evaluated the efficacy and tolerability of single-dose intravenous ferric carboxymaltose (FCM) in iron-deficient, premenopausal women with symptomatic, unexplained fatigue. METHODS: Fatigued women (Piper Fatigue Scale [PFS] score ≥5) with iron deficiency (ferritin <50 µg/L and transferrin saturation <20%, or ferritin <15 µg/L) and normal or borderline hemoglobin (≥115 g/L) were enrolled in 21 sites in Austria, Germany, Sweden and Switzerland, blinded to the study drug and randomized (computer-generated randomization sequence) to a single FCM (1000 mg iron) or saline (placebo) infusion. Primary endpoint was the proportion of patients with reduced fatigue (≥1 point decrease in PFS score from baseline to Day 56). RESULTS: The full analysis included 290 women (FCM 144, placebo 146). Fatigue was reduced in 65.3% (FCM) and 52.7% (placebo) of patients (OR 1.68, 95%CI 1.05-2.70; p = 0.03). A 50% reduction of PFS score was achieved in 33.3% FCM- vs. 16.4% placebo-treated patients (p<0.001). At Day 56, all FCM-treated patients had hemoglobin levels ≥120 g/L (vs. 87% at baseline); with placebo, the proportion decreased from 86% to 81%. Mental quality-of-life (SF-12) and the cognitive function scores improved better with FCM. 'Power of attention' improved better in FCM-treated patients with ferritin <15 µg/L. Treatment-emergent adverse events (placebo 114, FCM 209; most frequently headache, nasopharyngitis, pyrexia and nausea) were mainly mild or moderate. CONCLUSION: A single infusion of FCM improved fatigue, mental quality-of-life, cognitive function and erythropoiesis in iron-deficient women with normal or borderline hemoglobin. Although more side effects were reported compared to placebo, FCM can be an effective alternative in patients who cannot tolerate or use oral iron, the common treatment of iron deficiency. Overall, the results support the hypothesis that iron deficiency can affect women's health, and a normal iron status should be maintained independent of hemoglobin levels. TRIAL REGISTRATION: ClinicalTrials.gov NCT01110356.
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Iron supplementation reduces fatigue in nonanemic iron-deficient women.
“Iron supplementation thus helps in recovery from perceived fatigue above the placebo effect.”
From Vitamins and Minerals for Energy, Fatigue and Cognition: A Narrative Review of the Biochemical and Clinical Evidence (2020) · cites this paper as [130]
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- Authors
- Favrat, B., Balck, K., Breymann, C., Hedenus, M., Keller, T., Mezzacasa, A., & Gasche, C.
- Affiliations
- University of Lausanne (CH)
- University Hospital Zurich (CH)
- Sundsvall Municipality (SE)
- Vifor Pharma (Switzerland) (CH)
- Corresponding author
- Favrat, Bernard
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2014-04-21
- Volume
- 9
- Issue
- 4
- Pages
- e94217
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC3994001
- OpenAlex
- W2021092349
- Cited by
- 130
- References
- 45
- Citations by year
- 2026: 1 · 2025: 9 · 2024: 7 · 2023: 6 · 2022: 14 · 2021: 13 · 2020: 13 · 2019: 9 · 2018: 17 · 2017: 8 · 2016: 18 · 2015: 11 · 2014: 4
- FWCI
- 9.60
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- PLoS ONE (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, cc-by)
- IRIS (submittedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Figshare (submittedVersion, cc-by)
- SERVAL (Université de Lausanne) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, cc-by)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- European Hematology Association
- Les Laboratories Pierre Fabre
- Fresenius Medical Care North America
- Vifor Pharma
- Cilag
- Topics
- Health Sciences › Medicine › Hematology › Iron Metabolism and Disorders
- Health Sciences › Medicine › Hematology › Erythropoietin and Anemia Treatment
- Health Sciences › Medicine › Genetics › Hemoglobinopathies and Related Disorders
- Keywords
- ferric carboxymaltose, iron deficiency, unexplained fatigue, premenopausal women, intravenous iron, Piper Fatigue Scale, psychological quality of life, cognitive function, hemoglobin, erythropoiesis, treatment-emergent adverse events, single-dose infusion, low ferritin
- MeSH terms
- Iron Deficiencies, Adult, Cognition, Dose-Response Relationship, Drug, Erythrocyte Indices, Fatigue, Female, Ferric Compounds, Hemoglobins, Humans, Maltose, Placebos, Quality of Life, Transferrin, Endpoint Determination, Intention to Treat Analysis
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