Oral Cleft Prevention Trial in Brazil

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Cleft lip and palate are a significant component of morbid human birth defects in the developing world. By supplementing a high-risk group of women with folic acid (4.0 mg versus 0.4 mg) from preconception and continuing throughout the first 3 months of pregnancy in the state of Sao Paulo, Brazil, this study aims to reduce the recurrence of cleft lip and palate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NICHD Global Network for Women's and Children's Health
• Collaborators: Bill and Melinda Gates Foundation; Fogarty International Center of the National Institute of Health; Global Network for Women's and Children's Health Research; Hospital de Reabilitação de Anomalias Craniofaciais (HRAC) - Brazil; John E. Fogarty International Center (FIC); National Cancer Institute (NCI); National Center for Complementary and Integrative Health (NCCIH); National Institute of Dental and Craniofacial Research (NIDCR); RTI International; University of Iowa
• Treatments: Folic Acid; Vitamin B Complex

Criteria

Inclusion Criteria:

• All women must reside in the state where the clinic is located.

• Women with NSCL/P who attend the craniofacial clinics, who are 16 to 45 years of age (after age 45 fecundity decreases substantially)who attend the craniofacial clinic for their care.

• Women (ages 16 to 45 years of age) who have at least one natural child of any age with NSCL/P who receives care at the participating craniofacial clinics.

Exclusion Criteria:

• Cases resulting from consanguineous couples (first, second, and third degree, i.e., first cousins or closer).

• Couples where at least one of the two is definitely sterilized.

• Women on anti-epileptic drugs.

• Women who are pregnant.

• Women who are planning to move outside of the state where the clinic is located within the next year.

• Women who are planning to move outside of Sao Paulo state within the next year.

• Women who have B12 deficiency (B12 level is below 174 pg/ml or 134.328 pmol/L).

• Women who have an allergy to folic acid.