drugset / Trial / NCT00397917
Oral Cleft Prevention Program
Phase 3
Completed
4000 enrolled
University of Iowa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of Dental and Craniofacial Research (NIDCR) · collabRTI International · collabUniversity of Sao Paulo · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception and during the first three months of pregnancy decreases the risk of having a child with cleft lip and palate compared to 0.4 mg folic acid for women who have an oral cleft or have had previously child with an oral cleft.
Timeline
- Start
- 2006-11
- Primary completion
- 2012-05
- Completion
- 2013-07
Publications
- Results Vila-Nova C, Wehby GL, Queiros FC, Chakraborty H, Felix TM, Goco N, Moore J, Gewehr EV, Lins L, Affonso CM, Murray JC. Periconceptional use of folic acid and risk of miscarriage - findings of the Oral Cleft Prevention Program in Brazil. J Perinat Med. 2013 Jul;41(4):461-6. doi: 10.1515/jpm-2012-0173.
- Wehby GL, Goco N, Moretti-Ferreira D, Felix T, Richieri-Costa A, Padovani C, Queiros F, Guimaraes CV, Pereira R, Litavecz S, Hartwell T, Chakraborty H, Javois L, Murray JC. Oral cleft prevention program (OCPP). BMC Pediatr. 2012 Nov 26;12:184. doi: 10.1186/1471-2431-12-184.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | folic acid | Other / unclassified | 0.4 mg | — |
| Comparator | folic acid | Other / unclassified | 4 mg | — |