Overview

Oral Cleft Prevention Trial in Brazil

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