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Iron plus folate is more effective than iron alone in the treatment of iron deficiency anaemia in pregnancy: a randomised, double blind clinical trial
Author(s) -
JuarezVazquez Jorge,
Bonizzoni Erminio,
Scotti Aurelio
Publication year - 2002
Publication title -
bjog: an international journal of obstetrics and gynaecology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.157
H-Index - 164
eISSN - 1471-0528
pISSN - 1470-0328
DOI - 10.1111/j.1471-0528.2002.01378.x
Subject(s) - medicine , iron deficiency , pregnancy , tolerability , anemia , gastroenterology , quartile , population , folic acid , adverse effect , confidence interval , genetics , environmental health , biology
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 recommended in pregnant women with iron deficiency anaemia irrespective of the serum levels of folate.