drugset / Trial / NCT00098319
Oral Cleft Prevention Trial in Brazil
Phase 3
Completed
2200 enrolled
NICHD Global Network for Women's and Children's Health
Bill and Melinda Gates Foundation · collabFogarty International Center of the National Institute of Health · collabGlobal Network for Women's and Children's Health Research · collabHospital de Reabilitação de Anomalias Craniofaciais (HRAC) - Brazil · collabNational Cancer Institute (NCI) · collabNational Center for Complementary and Integrative Health (NCCIH) · collabNational Institute of Dental and Craniofacial Research (NIDCR) · collabRTI International · collabUniversity of Iowa · collab
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2004-01
- Primary completion
- —
- Completion
- 2007-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | folic acid | Other / unclassified | 0.4 mg | — |
| Subject | folic acid | Other / unclassified | 4 mg | — |