Iron plus folate is more effective than iron alone in the treatment of iron deficiency anaemia in pregnancy: a randomised, double blind clinical trial.
OBJECTIVE
To evaluate whether folate supplementation to iron is able to accelerate solving of iron deficiency anaemia in pregnancy.


METHODS
Multicentre, double blind, randomised clinical trial.


METHODS
Nine hospital gynaecologic units located in Mexico.


METHODS
Three hundred seventy-one women with iron deficiency anaemia between 14 and 27 weeks of pregnancy.


METHODS
Random allocation of the study population to receive 80 mg iron proteinsuccinylate, with or without 0.370 mg folinic acid daily for 60 days.


METHODS
Haemoglobin concentration increase.


RESULTS
Combined iron and folate therapy showed a better therapeutic response: the increase in haemoglobin levels from baseline was 1.42 (0.14) g/dL for women treated with both compounds vs 0.80 (0.125) g/dL for those given iron only (P < 0.001). A multivariable regression analysis showed that this effect was independent of basal levels of blood iron, ferritine and serum folate and was more evident in women with more severe anaemia. In the 64 women belonging to the subgroup defined by the per-protocol (PP) population and the lowest quartile of baseline haemoglobin values (mean 8.96, range 5.9-9.8 g/dL), the increase at day 60 was estimated 2.3 (0.53) g/dL for the combined therapy vs 0.5 (0.5) g/dL for iron only (P = 0.07). No significant differences in tolerability were observed between the two groups.


CONCLUSIONS
Folate supplementation is recommendedin pregnant women with iron deficiency anaemia irrespective of the serum levels of folate.
Juarez-Vazquez
Jorge
J
Dr Dario Fernandez Hospital, Mexico City, Mexico.
Bonizzoni
Erminio
E
Scotti
Aurelio
A
D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005293:Ferritins / Q000097:blood; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007501:Iron / Q000097:blood; D002955:Leucovorin / Q000008:administration & dosage*; D008667:Metalloproteins / Q000008:administration & dosage*; D015999:Multivariate Analysis; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000097:blood / Q000188:drug therapy*; D012044:Regression Analysis; D013386:Succinates / Q000008:administration & dosage*
D006454:Hemoglobins; D008667:Metalloproteins; D013386:Succinates; D005293:Ferritins; D007501:Iron; D002955:Leucovorin; C055066:iron protein succinylate