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. DESIGN: Multicentre, double blind, randomised clinical trial. SETTING: Nine hospital gynaecologic units located in Mexico. POPULATION: 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. MAIN OUTCOME MEASURE: 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. CONCLUSION: Folate supplementation is recommendedin pregnant women with iron deficiency anaemia irrespective of the serum levels of folate.