High dosage folic acid supplementation, oral cleft recurrence and fetal growth
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Outros Autores: | , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://dx.doi.org/10.3390/ijerph10020590 http://hdl.handle.net/11449/74544 |
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. © 2013 by the authors; licensee MDPI, Basel, Switzerland. |
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High dosage folic acid supplementation, oral cleft recurrence and fetal growthBirth defectsBrazilCleft lipCleft palateFolic acidNutritionOral cleftsPregnancyPreventionVitaminsfolic aciddrughealth carepregnancyvitaminwomens healthadolescentadultcell levelcleft lip palatecontrolled studydiet supplementationdrug blood leveldrug dose comparisondrug effectdrug megadosefamily historyfemalefetus growthfirst trimester pregnancyhigh risk pregnancyhistoric recurrence riskhumaninfantlive birthlow drug dosemulticenter study (topic)newbornoutcome assessmentpatient complianceprenatal carerandomized controlled trial (topic)recurrence riskrecurrent diseaseunspecified side effectAdultCleft LipCleft PalateDietary SupplementsDouble-Blind MethodFemaleFetal DevelopmentFolic AcidHumansVitamin B ComplexYoung AdultObjectives: 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 52242Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul 90035-903RTI International, Research Triangle Park, NC 27709Hospital de Reabilitação de Anomalias Craniofaciais, Bauru, Sao Paulo 17.043-900Department of Epidemiology and Biostatistics University of South Carolina, Columbia, SC 29208Centro de Atendimento Integral ao Fissurado Lábio Palatal, Curitiba, Paraná 81.050-000Instituto Materno Infantil Prof. Fernando Figueira-CADEFI/IMIP, Recife, Pernambuco 50070-550Hospital Santo Antônio: Obras Sociais Irmã Dulce, Salvador, Bahia 40.415-000Genetic Counseling Service São Paulo State University, Botucatu, Sao Paulo 18618-000Department of Pediatrics University of Iowa, Iowa City, IA 52242Genetic Counseling Service São Paulo State University, Botucatu, Sao Paulo 18618-000University of IowaHospital de Clínicas de Porto AlegreRTI International, Research Triangle ParkHospital de Reabilitação de Anomalias CraniofaciaisUniversity of South CarolinaCentro de Atendimento Integral ao Fissurado Lábio PalatalInstituto Materno Infantil Prof. Fernando Figueira-CADEFI/IMIPHospital Santo Antônio: Obras Sociais Irmã Dulce, SalvadorUniversidade Estadual Paulista (Unesp)Wehby, George L.Félix, Têmis MariaGoco, NormanRichieri-Costa, AntonioChakraborty, HrishikeshSouza, JosianePereira, RuiPadovani, CarlaMoretti-Ferreira, Danilo [UNESP]Murray, Jeffrey C.2014-05-27T11:28:21Z2014-05-27T11:28:21Z2013-02-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article590-605application/pdfhttp://dx.doi.org/10.3390/ijerph10020590International Journal of Environmental Research and Public Health, v. 10, n. 2, p. 590-605, 2013.1661-78271660-4601http://hdl.handle.net/11449/7454410.3390/ijerph10020590WOS:0003153965000122-s2.0-848749071732-s2.0-84874907173.pdf0000-0002-9256-7623Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengInternational Journal of Environmental Research and Public Health2.1450,7350,735info:eu-repo/semantics/openAccess2023-11-15T06:18:08Zoai:repositorio.unesp.br:11449/74544Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-05T17:47:39.703307Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
High dosage folic acid supplementation, oral cleft recurrence and fetal growth |
title |
High dosage folic acid supplementation, oral cleft recurrence and fetal growth |
spellingShingle |
High dosage folic acid supplementation, oral cleft recurrence and fetal growth Wehby, George L. 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 |
title_short |
High dosage folic acid supplementation, oral cleft recurrence and fetal growth |
title_full |
High dosage folic acid supplementation, oral cleft recurrence and fetal growth |
title_fullStr |
High dosage folic acid supplementation, oral cleft recurrence and fetal growth |
title_full_unstemmed |
High dosage folic acid supplementation, oral cleft recurrence and fetal growth |
title_sort |
High dosage folic acid supplementation, oral cleft recurrence and fetal growth |
author |
Wehby, George L. |
author_facet |
Wehby, George L. Félix, Têmis Maria Goco, Norman Richieri-Costa, Antonio Chakraborty, Hrishikesh Souza, Josiane Pereira, Rui Padovani, Carla Moretti-Ferreira, Danilo [UNESP] Murray, Jeffrey C. |
author_role |
author |
author2 |
Félix, Têmis Maria Goco, Norman Richieri-Costa, Antonio Chakraborty, Hrishikesh Souza, Josiane Pereira, Rui Padovani, Carla Moretti-Ferreira, Danilo [UNESP] Murray, Jeffrey C. |
author2_role |
author author author author author author author author author |
dc.contributor.none.fl_str_mv |
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) |
dc.contributor.author.fl_str_mv |
Wehby, George L. Félix, Têmis Maria Goco, Norman Richieri-Costa, Antonio Chakraborty, Hrishikesh Souza, Josiane Pereira, Rui Padovani, Carla Moretti-Ferreira, Danilo [UNESP] Murray, Jeffrey C. |
dc.subject.por.fl_str_mv |
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 |
topic |
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 |
description |
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. |
publishDate |
2013 |
dc.date.none.fl_str_mv |
2013-02-01 2014-05-27T11:28:21Z 2014-05-27T11:28:21Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://dx.doi.org/10.3390/ijerph10020590 International Journal of Environmental Research and Public Health, v. 10, n. 2, p. 590-605, 2013. 1661-7827 1660-4601 http://hdl.handle.net/11449/74544 10.3390/ijerph10020590 WOS:000315396500012 2-s2.0-84874907173 2-s2.0-84874907173.pdf 0000-0002-9256-7623 |
url |
http://dx.doi.org/10.3390/ijerph10020590 http://hdl.handle.net/11449/74544 |
identifier_str_mv |
International Journal of Environmental Research and Public Health, v. 10, n. 2, p. 590-605, 2013. 1661-7827 1660-4601 10.3390/ijerph10020590 WOS:000315396500012 2-s2.0-84874907173 2-s2.0-84874907173.pdf 0000-0002-9256-7623 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
International Journal of Environmental Research and Public Health 2.145 0,735 0,735 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
590-605 application/pdf |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
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1808128859227291648 |