Oral Cleft Prevention Trial in Brazil

NCT00098319 | Completed Phase 3

• 1 other identifier: GN 04 Aim III
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Cleft palate; Cleft lip; Folic acid; Global Network; Maternal and child health; International; Women's health; Brazil; Brasil; Latin America; ECLAMC; Congenital defects; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Recurrence of nonsyndromic cleft lip with or without cleft palate (NSCL/P) in offspring of trial mothers

Secondary Outcomes (9)

• Recurrence of NSCL/P compared to a historical control group; Overall and high versus low dose

• Serum and red cell folate levels

• Severity of NSCL/P in offspring of trial mothers

• Twinning rate

• Miscarriage rate

Interventions

Folic acid (0.4mg vs. 4.0mg) DRUG

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead
• Global Network for Women's and Children's Health Research: collaborator
• Bill and Melinda Gates Foundation: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Cancer Institute (NCI): collaborator
• RTI International: collaborator
• University of Iowa: collaborator
• Hospital de Reabilitação de Anomalias Craniofaciais (HRAC) - Brazil: collaborator

Study Sites (3)

Hospital de Reabilitação de Anomalias Craniofaciais (HRAC)

Bauru, São Paulo, Brazil

Location

Hospital de Clinicas de Porto Alegre (HCPA)

Porto Alegre, Brazil

Location

Hospital Santo Antonio-Centrinho: Obras Sociais Irma Dulce

Salvador, Brazil

Location

Related Links

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

MeSH Terms

Conditions

Cleft Lip; Cleft Palate; Congenital Abnormalities

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jeff Murray, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2004
• First Posted: December 7, 2004
• Study Start: January 1, 2004
• Study Completion: April 1, 2007
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

BR (3)