title: Safety and efficacy of lactoferrin versus ferrous sulphate in curing iron deficiency and iron deficiency anaemia in hereditary thrombophilia pregnant women: an interventional study.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier NCT01221844.
authors.affiliation: Department of Women's Health and Territorial Medicine, Sapienza University of Rome, Rome, Italy.
authors.forename: Rosalba
authors.initials: R
authors.lastname: Paesano
authors.forename: Enrica
authors.initials: E
authors.lastname: Pacifici
authors.forename: Samanta
authors.initials: S
authors.lastname: Benedetti
authors.forename: Francesca
authors.initials: F
authors.lastname: Berlutti
authors.forename: Alessandra
authors.initials: A
authors.lastname: Frioni
authors.forename: Antonella
authors.initials: A
authors.lastname: Polimeni
authors.forename: Piera
authors.initials: P
authors.lastname: Valenti
mesh_terms: D000022:Abortion, Spontaneous / Q000097:blood / Q000517:prevention & control; D000293:Adolescent; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000150:complications* / Q000188:drug therapy*; D000818:Animals; D002417:Cattle; D005260:Female; D005296:Ferrous Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D015850:Interleukin-6 / Q000097:blood; D007501:Iron / Q000097:blood; D000090463:Iron Deficiencies; D007781:Lactoferrin / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000097:blood / Q000188:drug therapy*; D019851:Thrombophilia / Q000097:blood / Q000150:complications* / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D005296:Ferrous Compounds; C508600:IL6 protein, human; D015850:Interleukin-6; C020748:ferrous sulfate; D007501:Iron; D007781:Lactoferrin