Randomized controlled trial of 4.0 mg versus 0.4 mg folic acid supplementation: Follow-up of children at 1 year of age
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) su...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-03-01
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| Series: | European Journal of Obstetrics & Gynecology and Reproductive Biology: X |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590161325000067 |
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| author | Renata Bortolus Francesca Filippini Sonia Cipriani Daniele Trevisanuto Federico Marchetti Pierpaolo Mastroiacovo Fabio Parazzini Francesco Cavallin |
| author_facet | Renata Bortolus Francesca Filippini Sonia Cipriani Daniele Trevisanuto Federico Marchetti Pierpaolo Mastroiacovo Fabio Parazzini Francesco Cavallin |
| author_sort | Renata Bortolus |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-cbb415fb49bc49f7ad576b356ccb3d0e |
| institution | DOAJ |
| issn | 2590-1613 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | European Journal of Obstetrics & Gynecology and Reproductive Biology: X |
| spelling | doaj-art-cbb415fb49bc49f7ad576b356ccb3d0e2025-08-20T03:02:47ZengElsevierEuropean Journal of Obstetrics & Gynecology and Reproductive Biology: X2590-16132025-03-012510037010.1016/j.eurox.2025.100370Randomized controlled trial of 4.0 mg versus 0.4 mg folic acid supplementation: Follow-up of children at 1 year of ageRenata Bortolus0Francesca Filippini1Sonia Cipriani2Daniele Trevisanuto3Federico Marchetti4Pierpaolo Mastroiacovo5Fabio Parazzini6Francesco Cavallin7Office for Research Promotion, Verona University Hospital, Verona 37134, ItalyOffice for Research Promotion, Verona University Hospital, Verona 37134, ItalyFondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca’ Granda Ospedale Maggiore Policlinico, Milan 20122, Italy; Correspondence to: Gynecology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, via della Commenda 12, Milan 20122, Italy.Department of Woman’s and Child’s Health, University of Padua, Padua 35128, ItalyDepartment of Pediatrics, Santa Maria Delle Croci Hospital, Ravenna, ItalyInternational Centre on Birth Defects-ICBD, Rome 00195, ItalyFondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca’ Granda Ospedale Maggiore Policlinico, Milan 20122, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan 20122, ItalyIndependent Statistician, Solagna 36020, ItalyObjective 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.http://www.sciencedirect.com/science/article/pii/S2590161325000067ChildrenDevelopmentFolic acidFollow-upHealth problemsBreastfeeding |
| spellingShingle | Renata Bortolus Francesca Filippini Sonia Cipriani Daniele Trevisanuto Federico Marchetti Pierpaolo Mastroiacovo Fabio Parazzini Francesco Cavallin Randomized controlled trial of 4.0 mg versus 0.4 mg folic acid supplementation: Follow-up of children at 1 year of age European Journal of Obstetrics & Gynecology and Reproductive Biology: X Children Development Folic acid Follow-up Health problems Breastfeeding |
| title | Randomized controlled trial of 4.0 mg versus 0.4 mg folic acid supplementation: Follow-up of children at 1 year of age |
| title_full | Randomized controlled trial of 4.0 mg versus 0.4 mg folic acid supplementation: Follow-up of children at 1 year of age |
| title_fullStr | Randomized controlled trial of 4.0 mg versus 0.4 mg folic acid supplementation: Follow-up of children at 1 year of age |
| title_full_unstemmed | Randomized controlled trial of 4.0 mg versus 0.4 mg folic acid supplementation: Follow-up of children at 1 year of age |
| title_short | Randomized controlled trial of 4.0 mg versus 0.4 mg folic acid supplementation: Follow-up of children at 1 year of age |
| title_sort | randomized controlled trial of 4 0 mg versus 0 4 mg folic acid supplementation follow up of children at 1 year of age |
| topic | Children Development Folic acid Follow-up Health problems Breastfeeding |
| url | http://www.sciencedirect.com/science/article/pii/S2590161325000067 |
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