Randomized controlled trial of 4.0 mg versus 0.4 mg folic acid supplementation: Follow-up of children at 1 year of age

IF 1.5 Q3 OBSTETRICS & GYNECOLOGY European Journal of Obstetrics and Gynecology and Reproductive Biology: X Pub Date : 2025-02-04 DOI:10.1016/j.eurox.2025.100370

Renata Bortolus , Francesca Filippini , Sonia Cipriani , Daniele Trevisanuto , Federico Marchetti , Pierpaolo Mastroiacovo , Fabio Parazzini , Francesco Cavallin , on behalf of the Italian Folic Acid Trial Study Group

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Abstract

Objective and study design

This 1-year follow-up study reports the results on the health status, visits to the paediatrician and hospitalizations of children born from the women recruited in the main randomized controlled trial (RCT) that investigated the effect of periconception folic acid (FA) supplementation of 4.0 mg/day on reducing adverse reproductive outcomes.

Methods

The health status of livebirths was evaluated by a trained health care provider (HCP) through a phone interview with the paediatrician (at 1–3–12 months of age) and with the parents (at 12 months of age), using a structured data collection form.

Results

Information at 1 year of life could be obtained for 347/376 (92.3 %) newborns included in the original RCT. No statistically significant differences were observed between the two groups regarding weight, health problems, hospitalizations from birth to 1 year of life and developmental milestones, as well as accesses to the emergency ward and parents’worries. Breastfeeding differed significantly at 1, 3 and 12 months of life, with higher proportion of exclusive breastfeeding in the 4.0 mg FA Group.

Conclusion

The findings suggest that the periconception FA supplementation of 4.0 mg/day versus 0.4 mg/day, does not affect the health status and hospitalizations from birth to 1 year of life, as well as normal child’s developmental milestones at 1 year of life. The increase in exclusive breastfeeding in the 4.0 mg FA group needs further investigation.

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