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dc.contributor.authorWehby, George L.pt_BR
dc.contributor.authorGoco, Normanpt_BR
dc.contributor.authorMoretti-Ferreira, Danilopt_BR
dc.contributor.authorFelix, Temis Mariapt_BR
dc.contributor.authorCosta, Antonio Richieri dapt_BR
dc.contributor.authorPadovani, Carlapt_BR
dc.contributor.authorQueirós, Fernandapt_BR
dc.contributor.authorGuimarães, Camilla Vilapt_BR
dc.contributor.authorPereira, Rui Manuel Rodriguespt_BR
dc.contributor.authorLitavecz, Stevept_BR
dc.contributor.authorHartwell, Tylerpt_BR
dc.contributor.authorChakraborty, Hrishikeshpt_BR
dc.contributor.authorJavois, Lorette C.pt_BR
dc.contributor.authorMurray, Jeffrey C.pt_BR
dc.date.accessioned2019-12-20T04:04:11Zpt_BR
dc.date.issued2012pt_BR
dc.identifier.issn1471-2431pt_BR
dc.identifier.urihttp://hdl.handle.net/10183/203624pt_BR
dc.description.abstractBackground: Oral clefts are one of the most common birth defects with significant medical, psychosocial, and economic ramifications. Oral clefts have a complex etiology with genetic and environmental risk factors. There are suggestive results for decreased risks of cleft occurrence and recurrence with folic acid supplements taken at preconception and during pregnancy with a stronger evidence for higher than lower doses in preventing recurrence. Yet previous studies have suffered from considerable design limitations particularly non-randomization into treatment. There is also well-documented effectiveness for folic acid in preventing neural tube defect occurrence at 0.4 mg and recurrence with 4 mg. Given the substantial burden of clefting on the individual and the family and the supportive data for the effectiveness of folic acid supplementation as well as its low cost, a randomized clinical trial of the effectiveness of high versus low dose folic acid for prevention of cleft recurrence is warranted. Methods/design: This study will assess the effect of 4 mg and 0.4 mg doses of folic acid, taken on a daily basis during preconception and up to 3 months of pregnancy by women who are at risk of having a child with nonsyndromic cleft lip with/without palate (NSCL/P), on the recurrence of NSCL/P. The total sample will include about 6,000 women (that either have NSCL/P or that have at least one child with NSCL/P) randomly assigned to the 4 mg and the 0.4 mg folic acid study groups. The study will also compare the recurrence rates of NSCL/P in the total sample of subjects, as well as the two study groups (4mg, 0.4 mg) to that of a historical control group. The study has been approved by IRBs (ethics committees) of all involved sites. Results will be disseminated through publications and presentations at scientific meetings. Discussion: The costs related to oral clefts are high, including long term psychological and socio-economic effects. This study provides an opportunity for huge savings in not only money but the overall quality of life. This may help establish more specific clinical guidelines for oral cleft prevention so that the intervention can be better tailored for at-risk women.en
dc.format.mimetypeapplication/pdfpt_BR
dc.language.isoengpt_BR
dc.relation.ispartofBMC pediatrics. London. Vol. 12 (Nov. 2012), p. 184, [33] p.pt_BR
dc.rightsOpen Accessen
dc.subjectFenda labialpt_BR
dc.subjectOral cleftsen
dc.subjectPrevenção de doençaspt_BR
dc.subjectCleft lipen
dc.subjectCleft palateen
dc.subjectFissura palatinapt_BR
dc.subjectSuplementos nutricionaispt_BR
dc.subjectCraniofacial anomaliesen
dc.subjectCongenital anomaliesen
dc.subjectCuidado pré-natalpt_BR
dc.subjectÁcido fólicopt_BR
dc.subjectBirth defectsen
dc.subjectFolic aciden
dc.subjectVitaminsen
dc.subjectPreventionen
dc.titleOral cleft prevention programa (OCPP)pt_BR
dc.typeArtigo de periódicopt_BR
dc.identifier.nrb000994866pt_BR
dc.type.originEstrangeiropt_BR


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