Efficacy and tolerability of oral bovine lactoferrin compared to ferrous sulfate in pregnant women with iron deficiency anemia: a prospective controlled randomized study.
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.
Nappi
Carmine
C
Department of Gynecology and Obstetrics, University of Naples Federico II, Via S. Pansini 5, Naples, Italy. nappi@unina.it
Tommaselli
Giovanni Antonio
GA
Morra
Ilaria
I
Massaro
Mariangela
M
Formisano
Carmen
C
Di Carlo
Costantino
C
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
D005296:Ferrous Compounds; D006397:Hematinics; C020748:ferrous sulfate; D007781:Lactoferrin