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Vitamin B12 deficiency in newborns: impact on individual’s health status and healthcare costs

  • Simona Ferraro EMAIL logo , Simona Lucchi , Chiara Montanari , Letizia Magnani , Martina Tosi , Davide Biganzoli , Andrea Lugotti , Laura Cappelletti , Alessia Poli , Elisa Pratiffi , Stephana Carelli , Laura Saielli , Luisella Alberti , Gianvincenzo Zuccotti , Marta Marsilio , Elvira Verduci and Cristina Cereda
Published/Copyright: October 3, 2024
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 3

Abstract

Objectives

The identification of vitamin B12 (B12) deficiency in the newborn may prevent neurological damage and a delay in the normal growth. In this study we characterized the incidence of B12 deficiency in newborns, the costs associated to the clinical diagnosis and management, and the relevance to optimize the use of cobalamin biomarkers during treatment follow-up.

Methods

Starting from a continuous case series of 146,470 screened newborns (November, 1st 2021- December, 3rd 2023), the Regional Reference Laboratory for Neonatal Screening identified 87 newborns having altered levels of biomarkers of cobalamin metabolism measured by newborn screening. These subjects were confirmed with a nutritional B12 deficiency of maternal origin by performing the serum B12 measurements and plasma homocysteine (Hcy) both on the newborns and respective mothers. A cost analysis was performed to characterize the costs/year of identifying and managing B12 deficiency cases.

Results

At baseline, median (interquartile range) serum B12 levels of 185.0 (142.3–246.0) ng/L and threefold increased plasma Hcy concentrations above the normal level confirmed a severe condition of deficiency in the newborns. After intramuscular B12 supplementation, serum B12 measured at the first follow up visit showed a fivefold increase, and the levels of Hcy returned to normal. From the healthcare perspective, the costs for diagnosing and managing all newborns with B12 deficiency is 188,480 €/year.

Conclusions

Preventing B12 depletion in newborns lowers healthcare costs and likely improves their health outcomes. Further studies are however required to address the clinical pathway to identify, treat and monitor pregnant women with marginal and low B12 status, in order to achieve these goals.

Keywords: vitamin; deficiency; supplementation; healthcare; cost; immunoassay
Corresponding author: Simona Ferraro, Center of Functional Genomics and Rare Diseases, Buzzi Children’s Hospital, Milan, Italy; and Department of Pediatrics, Buzzi Children’s Hospital, Milan, Italy, E-mail:
Simona Ferraro, Simona Lucchi, Chiara Montanari, Letizia Magnani contributed equally to this work. Elvira Verduci and Cristina Cereda are contributed equally as co-senior authors.

Acknowledgments

We thank the Regional Coordination Center for Laboratory Medicine of Lombardy for sharing the information from External Quality Assurance Services (EQAS) programs on the analytical performances of B12 and Hcy methods used in the laboratories of Lombardy.

  1. Research ethics: This study was approved by the Local Ethics Committee LOMBARDIA 1 (protocol n # CET 132-2023 of December 6, 2023). All procedures adhered to the guidelines of the Local Ethical Committee and have been performed in accordance with the ethical standards as laid down in the 1964 Helsinki Declaration and its later amendments. Informed consent was obtained for the treatment of anonymized data from a parent or a legal guardian.

  2. Informed consent: Informed consent was obtained for the treatment of anonymized data from a parent or a legal guardian.

  3. Author contributions: Simona Ferraro: conceptualization, writing the first draft; Simona Lucchi: conceptualization and performed the laboratory analysis; Chiara Montanari: involved in the collection of clinical data; Letizia Magnani: performed the cost analysis. Andrea Lugotti: involved in the collection of clinical data. Laura Saielli: performed the laboratory analysis; Elisa Pratiffi: performed the laboratory analysis; Davide Biganzoli: performed the statistical analysis; Alessia Poli: performed the cost analysis. Martina Tosi: involved in the collection of clinical data. Laura Cappeletti: performed the laboratory analysis. Luisella Alberti: performed the laboratory analysis; Stephana Carelli: collaborator involved in the interpretation of the results. Marta Marsilio: performed the cost analysis. Elvira Verduci: involved in the interpretation of the results; Gianvincenzo Zuccotti: reviewed the final version. Cristina Cereda: reviewed the final version.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Competing interests: The authors state no conflict of interest.

  6. Research funding: None to declare.

  7. Data availability: The raw data can be obtained on request from the corresponding author.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0692).

Received: 2024-06-13
Accepted: 2024-09-17
Published Online: 2024-10-03
Published in Print: 2025-02-25

© 2024 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2024-0692
Keywords for this article
vitamin; deficiency; supplementation; healthcare; cost; immunoassay

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Multi-cancer early detection: searching for evidence
  4. High sensitivity cardiac troponin assays, rapid myocardial infarction rule-out algorithms, and assay performance
  5. Reviews
  6. Consensus statement on extracellular vesicles in liquid biopsy for advancing laboratory medicine
  7. Copeptin as a diagnostic and prognostic biomarker in pediatric diseases
  8. Opinion Papers
  9. The Unholy Grail of cancer screening: or is it just about the Benjamins?
  10. Critical appraisal of the CLSI guideline EP09c “measurement procedure comparison and bias estimation using patient samples”
  11. Tumor markers determination in malignant pleural effusion: pearls and pitfalls
  12. Contribution of laboratory medicine and emerging technologies to cardiovascular risk reduction via exposome analysis: an opinion of the IFCC Division on Emerging Technologies
  13. Guidelines and Recommendations
  14. Recommendations for European laboratories based on the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease
  15. Genetics and Molecular Diagnostics
  16. Expanded carrier screening for 224 monogenic disease genes in 1,499 Chinese couples: a single-center study
  17. General Clinical Chemistry and Laboratory Medicine
  18. How do experts determine where to intervene on test ordering? An interview study
  19. New concept for control material in glucose point-of-care-testing for external quality assessment schemes
  20. Vitamin B12 deficiency in newborns: impact on individual’s health status and healthcare costs
  21. Analytical evaluation of eight qualitative FIT for haemoglobin products, for professional use in the UK
  22. Colorimetric correcting for sample concentration in stool samples
  23. Reference Values and Biological Variations
  24. Assessment of canonical diurnal variations in plasma glucose using quantile regression modelling and Chronomaps
  25. Inconsistency in ferritin reference intervals across laboratories: a major concern for clinical decision making
  26. Establishing the TSH reference intervals for healthy adults aged over 70 years: the Australian ASPREE cohort study
  27. Hematology and Coagulation
  28. The EuroFlow PIDOT external quality assurance scheme: enhancing laboratory performance evaluation in immunophenotyping of rare lymphoid immunodeficiencies
  29. Clinical value of smear review of flagged samples analyzed with the Sysmex XN hematology analyzer
  30. Cardiovascular Diseases
  31. Evidence for stability of cardiac troponin T concentrations measured with a high sensitivity TnT test in serum and lithium heparin plasma after six-year storage at −80 °C and multiple freeze-thaw cycles
  32. Letters to the Editor
  33. Impact of high-sensitivity cardiac troponin I assay imprecision on the safety of a single-sample rule-out approach for myocardial infarction
  34. Why is single sample rule out of non-ST elevation myocardial infarction using high-sensitivity cardiac troponin T safe when analytical imprecision is so high? A joint statistical and clinical demonstration
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