title: Efficacy and tolerability of oral bovine lactoferrin compared to ferrous sulfate in pregnant women with iron deficiency anemia: a prospective controlled randomized study.
abstract: OBJECTIVE
  To compare the effects of bovine lactoferrin with ferrous sulfate on iron nutritional status and to evaluate their tolerability in 100 pregnant women with iron deficiency anemia.
  
  
  METHODS
  Prospective, randomized, controlled, double blind trial.
  
  
  METHODS
  Obstetrics clinic of a University Department of Obstetrics and Gynecology.
  
  
  METHODS
  One-hundred pregnant, healthy women to be treated either with one capsule of 100 mg bovine lactoferrin twice a day (Group A; n=49) and 520 mg ferrous sulfate once a day (Group B; n=48).
  
  
  METHODS
  After 30 days, we evaluated hemoglobin (Hb), serum ferritin, serum iron and total iron- binding capacity (TIBC) values. All women were asked to keep a diary of five potential gastrointestinal side effects (abdominal pain, nausea, vomiting, diarrhea and constipation). For each symptom, patients had to rate its severity according to a scale ranging from 0 (absent) to 3 (severe).
  
  
  METHODS
  Hb level before and after treatment. Secondary outcomes were serum ferritin, serum iron and TIBC levels and the difference in symptom scores between groups.
  
  
  RESULTS
  In Groups A and B, Hb, serum ferritin and iron were significantly increased while TIBC was significantly reduced in comparison with basal values. No significant differences were observed between Groups A and B. The median scores of abdominal pain and constipation were significantly higher in patients treated with ferrous sulfate in comparison with those treated with bovine lactoferrin.
  
  
  CONCLUSIONS
  The results show that bovine lactoferrin has the same efficacy as ferrous sulfate in restoring iron deposits with significantly fewer gastrointestinal side effects.
authors.affiliation: Department of Gynecology and Obstetrics, University of Naples Federico II, Via S. Pansini 5, Naples, Italy. nappi@unina.it
authors.forename: Carmine
authors.initials: C
authors.lastname: Nappi
authors.forename: Giovanni Antonio
authors.initials: GA
authors.lastname: Tommaselli
authors.forename: Ilaria
authors.initials: I
authors.lastname: Morra
authors.forename: Mariangela
authors.initials: M
authors.lastname: Massaro
authors.forename: Carmen
authors.initials: C
authors.lastname: Formisano
authors.forename: Costantino
authors.initials: C
authors.lastname: Di Carlo
mesh_terms: D000284:Administration, Oral; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005296:Ferrous Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007781:Lactoferrin / Q000009:adverse effects / Q000627:therapeutic use*; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005296:Ferrous Compounds; D006397:Hematinics; C020748:ferrous sulfate; D007781:Lactoferrin