High dosage folic acid supplementation, oral cleft recurrence and fetal growth


Autoria(s): Wehby, George L.; Félix, Têmis Maria; Goco, Norman; Costa, Antonio Richieri da; Chakraborty, Hrishikesh; Souza, Josiane; Pereira, Rui; Padovani, Carla; Moretti-Ferreira, Danilo; Murray, Jeffrey C.
Contribuinte(s)

UNIVERSIDADE DE SÃO PAULO

Data(s)

02/10/2013

02/10/2013

2013

Resumo

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

Identificador

International Journal of Environmental Research and Public Health, Basel, v.10, n.2, p.590-605, Feb. 2013

1661-7827

http://www.producao.usp.br/handle/BDPI/33940

10.3390/ijerph10020590

http://www.mdpi.com/1660-4601/10/2/590

Idioma(s)

eng

Publicador

IJERPH Editorial Office

Basel

Relação

International Journal of Environmental Research and Public Health

Direitos

openAccess

IJERPH Editorial Office

Palavras-Chave #Oral clefts #Cleft lip #Cleft palate #Birth defects #Folic acid #Vitamins #Prevention #Pregnancy #Nutrition #Brazil #ÁCIDO FÓLICO #FISSURA LÁBIOPALATINA #RECIDIVA
Tipo

article

original article

publishedVersion