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High dosage folic acid supplementation, oral cleft recurrence and fetal growth
  • University of Iowa
  • Hospital de Clínicas de Porto Alegre
  • RTI International, Research Triangle Park
  • Hospital de Reabilitação de Anomalias Craniofaciais
  • University of South Carolina
  • Centro de Atendimento Integral ao Fissurado Lábio Palatal
  • Instituto Materno Infantil Prof. Fernando Figueira-CADEFI/IMIP
  • Hospital Santo Antônio: Obras Sociais Irmã Dulce, Salvador
  • Universidade Estadual Paulista (UNESP)
  • 1661-7827
  • 1660-4601
Objectives: To evaluate the effects of folic acid supplementation on isolated oral cleft recurrence and fetal growth. Patients and Methods: The 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. Results: The 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. Conclusions: The 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. © 2013 by the authors; licensee MDPI, Basel, Switzerland.
Issue Date: 
International Journal of Environmental Research and Public Health, v. 10, n. 2, p. 590-605, 2013.
Time Duration: 
  • Birth defects
  • Brazil
  • Cleft lip
  • Cleft palate
  • Folic acid
  • Nutrition
  • Oral clefts
  • Pregnancy
  • Prevention
  • Vitamins
  • folic acid
  • drug
  • health care
  • pregnancy
  • vitamin
  • womens health
  • adolescent
  • adult
  • cell level
  • cleft lip palate
  • controlled study
  • diet supplementation
  • drug blood level
  • drug dose comparison
  • drug effect
  • drug megadose
  • family history
  • female
  • fetus growth
  • first trimester pregnancy
  • high risk pregnancy
  • historic recurrence risk
  • human
  • infant
  • live birth
  • low drug dose
  • multicenter study (topic)
  • newborn
  • outcome assessment
  • patient compliance
  • prenatal care
  • randomized controlled trial (topic)
  • recurrence risk
  • recurrent disease
  • unspecified side effect
  • Adult
  • Cleft Lip
  • Cleft Palate
  • Dietary Supplements
  • Double-Blind Method
  • Female
  • Fetal Development
  • Folic Acid
  • Humans
  • Vitamin B Complex
  • Young Adult
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Appears in Collections:Artigos, TCCs, Teses e Dissertações da Unesp

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