Status:
COMPLETED
Oral Cleft Prevention Program
Lead Sponsor:
University of Iowa
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Cleft Lip
Cleft Palate
Eligibility:
FEMALE
16-45 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to asses if taking 4 mg of folic acid per day at preconception and during the first three months of pregnancy decreases the risk of having a child with cleft lip and palat...
Detailed Description
Cleft lip and palate is a common and burdensome birth defect that has large health ramifications and requires surgical, speech, behavioral, dental, and medical interventions. There is some evidence su...
Eligibility Criteria
Inclusion
- Women with cleft lip with/out palate (CLP), 16 to 45 years of age registered at the study clinics in Brazil or Women (16 to 45 years of age) with at least one natural child of any age with CLP registered at the study clinics.
- Women must reside in the catchment area of the study, which includes the states where the study clinics are located and surrounding states.
Exclusion
- Consanguineous couples (up to third degree, i.e. first cousins or closer).
- Pregnany at the time of recruitment. Women will be recontacted later at an appropriate time for participation in the study.
- Couples either one of which have been sterilized.
- Taking any form of seizure medication.
- Planning to move outside of the study catchment area within the next year.
- B12 deficiency (\<174 pg/mL or 129.15 pmol/L).
- Being allergic to folic acid.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT00397917
Start Date
November 1 2006
End Date
July 1 2013
Last Update
March 31 2017
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242