Oral cleft prevention program (OCPP)

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.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.NCT00397917Craniofacial anomalies comprise a significant component of morbid human birth defects. They require surgical, nutritional, dental, speech, medical, and behavioral interventions and impose a substantial economic burden. Clefts of the lip and palate affect about 1/700 births with wide variability related to geographic origin [1] and socioeconomic status [2]. The complex etiology of cleft lip with or without cleft palate (oral clefts) affords ample opportunities to identify environmental and gene-environment interactions and to establish programs for prevention.Numerous studies have looked at health inequalities and group differences on worldwide populations, often under the directorate of the World Health Organization (WHO) [3,4]. Mechanisms for measuring the burden of these diseases are controversial, but s