Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2022 May 19;14(10):2116.
doi: 10.3390/nu14102116.

Comparison of Ferric Sodium EDTA in Combination with Vitamin C, Folic Acid, Copper Gluconate, Zinc Gluconate, and Selenomethionine as Therapeutic Option for Chronic Kidney Disease Patients with Improvement in Inflammatory Status

Antonella Giliberti  1 , Annalisa Curcio  2 , Nicola Marchitto  3 , Luca Di Lullo  4 , Fulvia Paolozzi  5 , Fabiana Nano  2 , Michele Pironti  2 , Gianfranco Raimondi  6
Affiliations
Randomized Controlled Trial

Comparison of Ferric Sodium EDTA in Combination with Vitamin C, Folic Acid, Copper Gluconate, Zinc Gluconate, and Selenomethionine as Therapeutic Option for Chronic Kidney Disease Patients with Improvement in Inflammatory Status

Antonella Giliberti et al. Nutrients. .

Abstract

Anemia is one of the most frequent and earliest complications of chronic kidney disease (CKD), which impacts a patient’s quality of life and increases the risk of adverse clinical outcomes. Patients’ inflammatory status is strictly related to the occurrence of functional iron deficiency anemia (IDA) because this causes an increase in hepcidin levels with the consequent inhibition of iron absorption and release from cellular stores into blood circulation. The aim of this study was to evaluate the use of the new oral formulation based on ferric sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate, and selenomethionine (Ferachel Forte®) in patients with moderate CKD and functional IDA, analyzing the inflammatory status in addition to iron blood parameters, in comparison with oral ferrous sulfate and liposomal iron therapies. Sixty-two elderly patients were randomly allocated to one of the following oral treatments for 6 months: ferrous sulfate (Group 1; N = 20), ferric sodium EDTA in combination (Group 2; N = 22), and ferric liposomal formulation (Group 3; N = 20). The evaluated parameters included iron profile parameters of hemoglobin (Hb), sideremia, ferritin, transferrin saturation, C-reactive protein (CRP), and hepcidin. The results showed that in Group 1, there were no improvements. In Group 2, there were statistically significant (p < 0.001) improvements in all evaluated parameters. Finally, in Group 3, there were significant improvements in all evaluated parameters except for hepcidin, which was less than that of Group 2 patients. In conclusion, the findings showed the superior efficacy of the formulation based on ferric sodium EDTA over the other oral iron sources, and that this formulation can contribute to reducing the systemic inflammatory status in patients with CKD.

Keywords: C-reactive protein; chronic kidney disease; ferric sodium EDTA; ferritin; hepcidin; inflammation; iron deficiency anemia.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flow diagram of patient selection in the study.
See this image and copyright information in PMC

References

    1. Ramy M.H., Streja E., Kalantar-Zadeh K. Burden of Anemia in Chronic Kidney Disease: Beyond Erythropoietin. Adv. Ther. 2021;38:52–75. - PMC - PubMed
    1. Babitt J.L., Lin H.Y. Molecular Mechanisms of Hepcidin Regulation: Implications for the Anemia of CKD. Am. J. Kidney Dis. 2010;55:726–741. doi: 10.1053/j.ajkd.2009.12.030. - DOI - PMC - PubMed
    1. Awan A.A., Walther C.P., Richardson P.A., Shah M., Winkelmayer W.C., Navaneethan S.D. Prevalence, correlates and outcomes of absolute and functional iron deficiency anemia in nondialysis-dependent chronic kidney disease. Nephrol. Dial. Transpl. 2019;36:129–136. doi: 10.1093/ndt/gfz192. - DOI - PubMed
    1. Gafter-Gvili A., Schechter A., Rozen-Zvi B. Iron Deficiency Anemia in Chronic Kidney Disease. Acta Haematol. 2019;142:44–50. doi: 10.1159/000496492. - DOI - PubMed
    1. Camaschella C. Iron deficiency anemia. N. Engl. J. Med. 2015;372:1832–1843. doi: 10.1056/NEJMra1401038. - DOI - PubMed

Publication types