Status:
COMPLETED
Oral Cleft Prevention Trial in Brazil
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborating Sponsors:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
Conditions:
Cleft Lip
Cleft Palate
Eligibility:
FEMALE
16-45 years
Phase:
PHASE3
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 preconce...
Detailed Description
Craniofacial anomalies and cleft lip with or without cleft palate (CL/P) are a model for the impact of birth defects on fetal and neonatal health directly and maternal health indirectly. Craniofacial ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT00098319
Start Date
January 1 2004
End Date
April 1 2007
Last Update
December 17 2013
Active Locations (3)
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1
Hospital de Reabilitação de Anomalias Craniofaciais (HRAC)
Bauru, São Paulo, Brazil
2
Hospital de Clinicas de Porto Alegre (HCPA)
Porto Alegre, Brazil
3
Hospital Santo Antonio-Centrinho: Obras Sociais Irma Dulce
Salvador, Brazil