BioMetals

, Volume 27, Issue 5, pp 999–1006

Safety and efficacy of lactoferrin versus ferrous sulphate in curing iron deficiency and iron deficiency anaemia in hereditary thrombophilia pregnant women: an interventional study

  • Rosalba Paesano
  • Enrica Pacifici
  • Samanta Benedetti
  • Francesca Berlutti
  • Alessandra Frioni
  • Antonella Polimeni
  • Piera Valenti
Article

DOI: 10.1007/s10534-014-9723-x

Cite this article as:
Paesano, R., Pacifici, E., Benedetti, S. et al. Biometals (2014) 27: 999. doi:10.1007/s10534-014-9723-x

Abstract

Objective Evaluate the safety and efficacy of bovine lactoferrin (bLf) versus the ferrous sulphate standard intervention in curing iron deficiency (ID) and ID anaemia (IDA) in pregnant women affected by hereditary thrombophilia (HT). Design Interventional study. Setting Secondary-level hospital for complicated pregnancies in Rome, Italy. Population 295 HT pregnant women (≥18 years) suffering from ID/IDA. Methods Women were enrolled in Arm A or B in accordance with their personal choice. In Arm A, 156 women received oral administration of 100 mg of bLf twice a day; in Arm B, 139 women received 520 mg of ferrous sulphate once a day. Therapies lasted until delivery. Main outcome measures Red blood cells, haemoglobin, total serum iron, serum ferritin (haematological parameters) were assayed before and every 30 days during therapy until delivery. Serum IL-6, key factor in inflammatory and iron homeostasis disorders, was detected at enrolment and after therapy at delivery. Possible maternal, foetal, and neonatal adverse effects were assessed. Results Haematological parameters were significantly higher in Arm A than in Arm B pregnant women (P ≤ 0.0001). Serum IL-6 significantly decreased in bLf-treated women and increased in ferrous sulphate-treated women. BLf did not exert any adverse effect. Adverse effects in 16.5 % of ferrous sulphate-treated women were recorded. Arm A women experienced no miscarriage compared to five miscarriages in Arm B women. Conclusions Differently from ferrous sulphate, bLf is safe and effective in curing ID/IDA associated with a consistent decrease of serum IL-6. The absence of miscarriage among bLf-treated women provided an unexpected benefit. Trial registration: ClinicalTrials.gov Identifier NCT01221844.

Keywords

LactoferrinAnaemiaIron deficiencyPregnancyHereditary thrombophilia

Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Rosalba Paesano
    • 1
    • 2
  • Enrica Pacifici
    • 3
  • Samanta Benedetti
    • 3
  • Francesca Berlutti
    • 4
  • Alessandra Frioni
    • 4
  • Antonella Polimeni
    • 5
  • Piera Valenti
    • 4
  1. 1.Department of Women’s Health and Territorial MedicineSapienza University of RomeRomeItaly
  2. 2.Clinica Fabia MaterRomeItaly
  3. 3.Clinica Santa FamigliaRomeItaly
  4. 4.Department of Public Health and Infectious DiseasesSapienza University of RomeRomeItaly
  5. 5.Department of Oral Sciences and Maxillofacial SurgerySapienza University of RomeRomeItaly