High Dosage Folic Acid Supplementation, Oral Cleft Recurrence and Fetal Growth

被引:27
作者
Wehby, George L. [1 ]
Felix, Temis Maria [2 ]
Goco, Norman [3 ]
Richieri-Costa, Antonio [4 ]
Chakraborty, Hrishikesh [5 ]
Souza, Josiane [6 ]
Pereira, Rui [7 ]
Padovani, Carla [8 ]
Moretti-Ferreira, Danilo [9 ]
Murray, Jeffrey C. [10 ]
机构
[1] Univ Iowa, Dept Hlth Management & Policy, Iowa City, IA 52242 USA
[2] Hosp Clin Porto Alegre, BR-90035903 Porto Alegre, RS, Brazil
[3] RTI Int, Res Triangle Pk, NC 27709 USA
[4] Hosp Reabilitacao Anomalias Craniofaciais, BR-17043900 Sao Paulo, Brazil
[5] Univ S Carolina, Dept Epidemiol & Biostat, Columbia, SC 29208 USA
[6] Ctr Atendimento Integral Fissurado Labio Palatal, BR-81050000 Curitiba, Parana, Brazil
[7] Inst Materno Infantil Prof Fernando Figueira CADE, BR-50070550 Recife, PE, Brazil
[8] Hosp Santo Antonio Obras Sociais Irma Dulce, BR-40415000 Salvador, BA, Brazil
[9] Sao Paulo State Univ, Genet Counseling Serv, BR-18618000 Sao Paulo, Brazil
[10] Univ Iowa, Dept Pediat, Iowa City, IA 52242 USA
关键词
oral clefts; cleft lip; cleft palate; birth defects; folic acid; vitamins; prevention; pregnancy; nutrition; Brazil; QUALITY-OF-LIFE; MATERNAL SMOKING; OROFACIAL CLEFTS; LIP; VARIANTS;
D O I
10.3390/ijerph10020590
中图分类号
X [环境科学、安全科学];
学科分类号
08 ; 0830 ;
摘要
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.
引用
收藏
页码:590 / 605
页数:16
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