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

dc.contributorUniversidade Estadual Paulista (UNESP)
dc.creatorWehby, George L.
dc.creatorFélix, Têmis Maria
dc.creatorGoco, Norman
dc.creatorRichieri-Costa, Antonio
dc.creatorChakraborty, Hrishikesh
dc.creatorSouza, Josiane
dc.creatorPereira, Rui
dc.creatorPadovani, Carla
dc.creatorMoretti-Ferreira, Danilo
dc.creatorMurray, Jeffrey C.
dc.date2014-05-27T11:28:21Z
dc.date2016-10-25T18:43:31Z
dc.date2014-05-27T11:28:21Z
dc.date2016-10-25T18:43:31Z
dc.date2013-02-01
dc.date.accessioned2017-04-06T02:12:36Z
dc.date.available2017-04-06T02:12:36Z
dc.identifierInternational Journal of Environmental Research and Public Health, v. 10, n. 2, p. 590-605, 2013.
dc.identifier1661-7827
dc.identifier1660-4601
dc.identifierhttp://hdl.handle.net/11449/74544
dc.identifierhttp://acervodigital.unesp.br/handle/11449/74544
dc.identifier10.3390/ijerph10020590
dc.identifierWOS:000315396500012
dc.identifier2-s2.0-84874907173.pdf
dc.identifier2-s2.0-84874907173
dc.identifier0000-0002-9256-7623
dc.identifierhttp://dx.doi.org/10.3390/ijerph10020590
dc.identifier.urihttp://repositorioslatinoamericanos.uchile.cl/handle/2250/895307
dc.descriptionObjectives: 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.
dc.languageeng
dc.relationInternational Journal of Environmental Research and Public Health
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectBirth defects
dc.subjectBrazil
dc.subjectCleft lip
dc.subjectCleft palate
dc.subjectFolic acid
dc.subjectNutrition
dc.subjectOral clefts
dc.subjectPregnancy
dc.subjectPrevention
dc.subjectVitamins
dc.subjectfolic acid
dc.subjectdrug
dc.subjecthealth care
dc.subjectpregnancy
dc.subjectvitamin
dc.subjectwomens health
dc.subjectadolescent
dc.subjectadult
dc.subjectcell level
dc.subjectcleft lip palate
dc.subjectcontrolled study
dc.subjectdiet supplementation
dc.subjectdrug blood level
dc.subjectdrug dose comparison
dc.subjectdrug effect
dc.subjectdrug megadose
dc.subjectfamily history
dc.subjectfemale
dc.subjectfetus growth
dc.subjectfirst trimester pregnancy
dc.subjecthigh risk pregnancy
dc.subjecthistoric recurrence risk
dc.subjecthuman
dc.subjectinfant
dc.subjectlive birth
dc.subjectlow drug dose
dc.subjectmulticenter study (topic)
dc.subjectnewborn
dc.subjectoutcome assessment
dc.subjectpatient compliance
dc.subjectprenatal care
dc.subjectrandomized controlled trial (topic)
dc.subjectrecurrence risk
dc.subjectrecurrent disease
dc.subjectunspecified side effect
dc.subjectAdult
dc.subjectCleft Lip
dc.subjectCleft Palate
dc.subjectDietary Supplements
dc.subjectDouble-Blind Method
dc.subjectFemale
dc.subjectFetal Development
dc.subjectFolic Acid
dc.subjectHumans
dc.subjectVitamin B Complex
dc.subjectYoung Adult
dc.titleHigh dosage folic acid supplementation, oral cleft recurrence and fetal growth
dc.typeOtro


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