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- Title
Efficacy of 4.0 mg versus 0.4 mg Folic Acid Supplementation on the Reproductive Outcomes: A Randomized Controlled Trial.
- Authors
Bortolus, Renata; Filippini, Francesca; Cipriani, Sonia; Trevisanuto, Daniele; Cavallin, Francesco; Zanconato, Giovanni; Somigliana, Edgardo; Cesari, Elena; Mastroiacovo, Pierpaolo; Parazzini, Fabio
- Abstract
Folic acid (FA) supplementation prevents neural tube defects (NTDs), but the effects on other reproductive outcomes are unclear. While common recommendation is 0.4 mg/day in addition to regular nutrition, the most appropriate dose of FA is still under debate. We investigated the effects of a higher dose of periconception FA on reducing adverse reproductive outcomes. In this multicenter double-blind randomized controlled trial (RCT), 1060 women (aged 18–44 years and planning a pregnancy) were randomly assigned to receive 4.0 mg or 0.4 mg of FA daily. The primary outcome was the occurrence of congenital malformations (CMs). A composite outcome including one or more adverse pregnancy outcomes was also evaluated. A total of 431 women had a natural conception within 1 year. The primary outcome occurred in 8/227 (3.5%) women receiving 4.0 mg FA and 9/204 (4.4%) women receiving 0.4 mg FA (RR 0.80; 95%CI 0.31 to 2.03). The composite outcome occurred in 43/227 (18.9%) women receiving 4.0 mg FA and 75/204 (36.8%) women receiving 0.4 mg FA (RR 0.51; 95%CI 0.40 to 0.68). FA 4.0 mg supplementation was not associated with different occurrence of CMs, compared to FA 0.4 mg supplementation. However, FA 4.0 mg supplementation was associated with lower occurrence of other adverse pregnancy outcomes.
- Subjects
NEURAL tube defect prevention; DRUG efficacy; CONFIDENCE intervals; DIETARY supplements; PREGNANCY outcomes; RANDOMIZED controlled trials; DESCRIPTIVE statistics; FOLIC acid; STATISTICAL sampling; DOSE-response relationship in biochemistry; REPRODUCTIVE health; WOMEN'S health
- Publication
Nutrients, 2021, Vol 13, Issue 12, p4422
- ISSN
2072-6643
- Publication type
Academic Journal
- DOI
10.3390/nu13124422