Oral Cleft Prevention Program

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Iowa
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of Dental and Craniofacial Research (NIDCR); RTI International; University of Sao Paulo
• Treatments: Folic Acid; Vitamin B Complex

Criteria

Inclusion Criteria:

• Women with cleft lip with/out palate (CLP), 16 to 45 years of age registered at the study clinics in Brazil or Women (16 to 45 years of age) with at least one natural child of any age with CLP registered at the study clinics.

• Women must reside in the catchment area of the study, which includes the states where the study clinics are located and surrounding states.

Exclusion Criteria:

• Consanguineous couples (up to third degree, i.e. first cousins or closer).

• Pregnany at the time of recruitment. Women will be recontacted later at an appropriate time for participation in the study.

• Couples either one of which have been sterilized.

• Taking any form of seizure medication.

• Planning to move outside of the study catchment area within the next year.

• B12 deficiency (<174 pg/mL or 129.15 pmol/L).

• Being allergic to folic acid.