title: Oral cleft prevention program (OCPP).
abstract: BACKGROUND
  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
  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 (4 mg, 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.
  
  
  CONCLUSIONS
  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. CLINICALTRIALS.GOV IDENTIFIER: NCT00397917.
authors.affiliation: University of Iowa, Iowa City, IA, USA.
authors.forename: George L
authors.initials: GL
authors.lastname: Wehby
authors.forename: Norman
authors.initials: N
authors.lastname: Goco
authors.forename: Danilo
authors.initials: D
authors.lastname: Moretti-Ferreira
authors.forename: Temis
authors.initials: T
authors.lastname: Felix
authors.forename: Antonio
authors.initials: A
authors.lastname: Richieri-Costa
authors.forename: Carla
authors.initials: C
authors.lastname: Padovani
authors.forename: Fernanda
authors.initials: F
authors.lastname: Queiros
authors.forename: Camilla Vila Nova
authors.initials: CV
authors.lastname: Guimaraes
authors.forename: Rui
authors.initials: R
authors.lastname: Pereira
authors.forename: Steve
authors.initials: S
authors.lastname: Litavecz
authors.forename: Tyler
authors.initials: T
authors.lastname: Hartwell
authors.forename: Hrishikesh
authors.initials: H
authors.lastname: Chakraborty
authors.forename: Lorette
authors.initials: L
authors.lastname: Javois
authors.forename: Jeffrey C
authors.initials: JC
authors.lastname: Murray
mesh_terms: D002971:Cleft Lip / Q000517:prevention & control*; D002972:Cleft Palate / Q000517:prevention & control*; D002985:Clinical Protocols; D019587:Dietary Supplements; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005492:Folic Acid / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D010865:Pilot Projects; D016742:Preconception Care / Q000379:methods*; D011247:Pregnancy; D011295:Prenatal Care / Q000379:methods*; D012107:Research Design; D055502:Secondary Prevention; D014803:Vitamin B Complex / Q000627:therapeutic use*
chemical_list: D014803:Vitamin B Complex; D005492:Folic Acid