Trial reportInternational journal of environmental research and public health2013
High dosage folic acid supplementation, oral cleft recurrence and fetal growth.
Trial report in International journal of environmental research and public health, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Preconception and periconception interventions to prevent low birth weight, small for gestational age and preterm birth: a systematic review and meta-analysis.BMJ global health · 2022Pooled it
- Vitamin supplementation for preventing miscarriage.The Cochrane database of systematic reviews · 2016Pooled it
- Effects and safety of periconceptional oral folate supplementation for preventing birth defects.The Cochrane database of systematic reviews · 2015Pooled it
- Uncovering the Hidden Dangers and Molecular Mechanisms of Excess Folate: A Narrative Review.Nutrients · 2023Review
- Academic outcomes of children with orofacial clefts: A review of the literature and recommendations for future research.Oral diseases · 2022Review
- Maternal periconceptional folic acid supplementation reduced risks of non-syndromic oral clefts in offspring.Scientific reports · 2021Article
- Effects of preconception care and periconception interventions on maternal nutritional status and birth outcomes in low- and middle-income countries: A systematic review.Campbell systematic reviews · 2021Review
- Maternal Folic Acid Deficiency Is Associated to Developing Nasal and Palate Malformations in Mice.Nutrients · 2021Article
- Efficacy of Periconceptional High-Dose Folic Acid in Isolated Orofacial Cleft Prevention: A Systematic Review.Indian journal of plastic surgery : official publication of the Association of Plastic Surgeons of India · 2019Review
- Maternal folic acid supplementation reduces the severity of cleft palate in Tgf-βPediatric research · 2019Article
- The pharmacokinetic advantage of 5-methyltetrahydrofolate for minimization of the risk for birth defects.Scientific reports · 2018Article
- Maternal underweight and obesity and risk of orofacial clefts in a large international consortium of population-based studies.International journal of epidemiology · 2017Article
- Article
- Evaluating the role of maternal folic acid supplementation in modifying the effects of methylenetetrahydrofolate reductase (C677T and A1298C) gene polymorphisms in oral cleft children.Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences · 2016Article
- Folic acid supplementation in pregnancy and implications in health and disease.Journal of biomedical science · 2014Review
- Oral cleft recurrence risk and subsequent maternal fertility preferences and behavior in Brazil.Birth defects research. Part A, Clinical and molecular teratology · 2014Article
- Folic Acid Fortification and Women's Folate Levels in Selected Communities in Brazil - A First Look.International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition · 2014Article
- Gestational folate deficiency alters embryonic gene expression and cell function.Differentiation; research in biological diversityArticle
- The impact of folic acid supplementation on gestational and long term health: Critical temporal windows, benefits and risks.Porto biomedical journalReview
Corrections and comments
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Authors and funding
10 authors.
Funding
Abstract
objectivesTo evaluate the effects of folic acid supplementation on isolated oral cleft recurrence and fetal growth. PATIENTS AND
methodsThe study included 2,508 women who were at-risk for oral cleft recurrence and randomized into two folic acid supplementation groups: 0.4 and 4 mg per day before pregnancy and throughout the first trimester. The infant outcome data were based on 234 live births. In addition to oral cleft recurrence, several secondary outcomes were compared between the two folic acid groups. Cleft recurrence rates were also compared to historic recurrence rates.
resultsThe oral cleft recurrence rates were 2.9% and 2.5% in the 0.4 and 4 mg groups, respectively. The recurrence rates in the two folic acid groups both separately and combined were significantly different from the 6.3% historic recurrence rate post the folic acid fortification program for this population (p = 0.0009 when combining the two folic acid groups). The rate of cleft lip with palate recurrence was 2.9% in the 0.4 mg group and 0.8% in the 4 mg group. There were no elevated fetal growth complications in the 4 mg group compared to the 0.4 mg group.
conclusionsThe study is the first double-blinded randomized clinical trial (RCT) to study the effect of high dosage folic acid supplementation on isolated oral cleft recurrence. The recurrence rates were similar between the two folic acid groups. However, the results are suggestive of a decrease in oral cleft recurrence compared to the historic recurrence rate. A RCT is still needed to identify the effect of folic acid on oral cleft recurrence given these suggestive results and the supportive results from previous interventional and observational studies, and the study offers suggestions for such future studies. The results also suggest that high dosage folic acid does not compromise fetal growth.
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