1. High Dosage Folic Acid Supplementation, Oral Cleft Recurrence and Fetal Growth
- Author
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Hrishikesh Chakraborty, Carla Padovani, George L. Wehby, Têmis Maria Félix, Antonio Richieri-Costa, Norman Goco, Rui Pereira, Danilo Moretti-Ferreira, Jeffrey C. Murray, Josiane Souza, 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, and Universidade Estadual Paulista (Unesp)
- Subjects
oral clefts ,cleft lip ,cleft palate ,birth defects ,folic acid ,vitamins ,prevention ,pregnancy ,nutrition ,+<%2Fspan>%22">Brazil ,drug megadose ,Folic acid ,recurrent disease ,Health, Toxicology and Mutagenesis ,lcsh:Medicine ,Gastroenterology ,law.invention ,low drug dose ,Fetal Development ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,newborn ,Pregnancy ,law ,030212 general & internal medicine ,randomized controlled trial (topic) ,Young adult ,Brazil  ,family history ,0303 health sciences ,education.field_of_study ,adult ,drug effect ,vitamin ,drug ,Vitamins ,health care ,3. Good health ,Cleft Palate ,cell level ,drug dose comparison ,female ,diet supplementation ,Vitamin B Complex ,multicenter study (topic) ,Female ,prenatal care ,Live birth ,Brazil ,recurrence risk ,Adult ,Vitamin ,medicine.medical_specialty ,Cleft Lip ,Population ,first trimester pregnancy ,RECIDIVA ,Prenatal care ,patient compliance ,live birth ,Article ,Oral clefts ,Young Adult ,03 medical and health sciences ,fetus growth ,Double-Blind Method ,Internal medicine ,medicine ,Humans ,cleft lip palate ,controlled study ,human ,education ,outcome assessment ,unspecified side effect ,Nutrition ,030304 developmental biology ,historic recurrence risk ,high risk pregnancy ,Oral cleft ,business.industry ,Prevention ,lcsh:R ,Public Health, Environmental and Occupational Health ,womens health ,medicine.disease ,infant ,Surgery ,Birth defects ,chemistry ,adolescent ,drug blood level ,Dietary Supplements ,business ,NCT00397917 - Abstract
Submitted by Vitor Silverio Rodrigues (vitorsrodrigues@reitoria.unesp.br) on 2014-05-27T11:28:21Z No. of bitstreams: 0Bitstream added on 2014-05-27T14:42:48Z : No. of bitstreams: 1 2-s2.0-84874907173.pdf: 495846 bytes, checksum: 189c6061fc03b14fb90ebe22cd2d8359 (MD5) Made available in DSpace on 2014-05-27T11:28:21Z (GMT). No. of bitstreams: 0 Previous issue date: 2013-02-01 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. Department of Health Management and Policy University of Iowa, Iowa City, IA 52242 Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90035-903 RTI International, Research Triangle Park, NC 27709 Hospital de Reabilitação de Anomalias Craniofaciais, Bauru, Sao Paulo 17.043-900 Department of Epidemiology and Biostatistics University of South Carolina, Columbia, SC 29208 Centro de Atendimento Integral ao Fissurado Lábio Palatal, Curitiba, Paraná 81.050-000 Instituto Materno Infantil Prof. Fernando Figueira-CADEFI/IMIP, Recife, Pernambuco 50070-550 Hospital Santo Antônio: Obras Sociais Irmã Dulce, Salvador, Bahia 40.415-000 Genetic Counseling Service São Paulo State University, Botucatu, Sao Paulo 18618-000 Department of Pediatrics University of Iowa, Iowa City, IA 52242 Genetic Counseling Service São Paulo State University, Botucatu, Sao Paulo 18618-000
- Published
- 2013