The most common public health recommendation to prevent the occurrence of neural tube defects (NTDs), and possibly other congenital malformations (CMs), is to take a folic acid (FA) supplement containing 0.4 mg/day, however the question of the most appropriate dose of FA and the role of other B-vitamins is still open. To evaluate this issues we have planned a randomized, double-blind, controlled trial (RCT) to assess the effect of FA periconceptional supplementation of 4 mg/day compared to the 0.4 mg/day standard dose on reducing the occurrence of all CMs and to promote an international prospective meta-analysis (PMA). The RCT will start in 2009 in the Veneto Region, Italy. Similar studies that will be part of the PMA are already planned in The Netherlands (2010) and in Hungary.
RCT to evaluate the efficacy of high dose of folic acid to prevent the occurrence of birth defects
BORTOLUS, Renata;
2009-01-01
Abstract
The most common public health recommendation to prevent the occurrence of neural tube defects (NTDs), and possibly other congenital malformations (CMs), is to take a folic acid (FA) supplement containing 0.4 mg/day, however the question of the most appropriate dose of FA and the role of other B-vitamins is still open. To evaluate this issues we have planned a randomized, double-blind, controlled trial (RCT) to assess the effect of FA periconceptional supplementation of 4 mg/day compared to the 0.4 mg/day standard dose on reducing the occurrence of all CMs and to promote an international prospective meta-analysis (PMA). The RCT will start in 2009 in the Veneto Region, Italy. Similar studies that will be part of the PMA are already planned in The Netherlands (2010) and in Hungary.
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