Evidence map›Paper›PMID 35631257›Full record

Trial reportNutrients2022

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, Annalisa Curcio, Nicola Marchitto, Luca Di Lullo, Fulvia Paolozzi, Fabiana Nano, Michele Pironti, Gianfranco Raimondi

Open access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Nutrients, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
3.8field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Antioxidants for adults with chronic kidney disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 1 country.

Antonella GilibertiDepartment of Nephrology and Dialysis, "Santa Maria delle Grazie" Hospital Pozzuoli, 80078 Naples, Italy.
Annalisa CurcioMedical Department, Aqma Italia S.p.A., 80138 Naples, Italy.ORCID 0000-0002-0091-8247
Nicola MarchittoDepartment of Internal Medicine, "San Giovanni di Dio" Hospital, 04022 Fondi, Italy.
Luca Di LulloDepartment of Nephrology and Dialysis, "L. Parodi-Delfino" Hospital, 00034 Colleferro, Italy.
Fulvia PaolozziDepartment of Pharmacy, Pellegrini Hospital, 80134 Naples, Italy.
Fabiana NanoMedical Department, Aqma Italia S.p.A., 80138 Naples, Italy.
Michele PirontiMedical Department, Aqma Italia S.p.A., 80138 Naples, Italy.
Gianfranco RaimondiDepartment of Medico-Surgical Sciences and Biotechnologies, Faculty of Internal Medicine, "Sapienza" University of Rome, 04100 Latina, Italy.
CTO Hospital · ITNuovo Ospedale San Giovanni di Dio · ITOspedale dei Pellegrini · ITOspedale Santa Maria · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Anemia, Iron-DeficiencyRenal Insufficiency, ChronicAgedAntioxidantsAscorbic AcidEdetic AcidFolic AcidGluconatesHepcidinsHumansIronQuality of LifeSelenomethionineSodiumVitaminsAntioxidantsAscorbic AcidEdetic AcidFolic AcidGluconatesgluconic acidHepcidinsIronSelenomethionineSodiumVitaminschronic kidney diseaseC-reactive proteinferric sodium EDTAferritinhepcidininflammationiron deficiency anemia

Identifiers

PMID35631257
PMCPMC9145680
OpenAlexW4280581357

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.