Oral Cleft Prevention Trial in Brazil

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.

Conditions

• Cleft Lip
• Cleft Palate

Interventions

DRUG

Folic acid (0.4mg vs. 4.0mg)

Sponsors & Collaborators

• Global Network for Women's and Children's Health Research

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• National Institute of Dental and Craniofacial Research (NIDCR)

  collaborator NIH

• Fogarty International Center of the National Institute of Health

  collaborator NIH

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• RTI International

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• Hospital de Reabilitação de Anomalias Craniofaciais (HRAC) - Brazil

  collaborator OTHER

• NICHD Global Network for Women's and Children's Health

  lead NETWORK

Principal Investigators

• Jeff Murray, M.D. · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-01-31

Completion

2007-04-30

Countries

• Brazil

Study Locations