Oral Cleft Prevention Program
Completed · Phase 3
Conditions studied: Cleft Lip, Cleft Palate
In brief
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 palate compared to 0.4 mg folic acid for women who have an oral cleft or have had previously child with an oral cleft.
Key facts
- Study ID
- NCT00397917
- Run by
- University of Iowa
- People needed
- 4000
- Starts
- 2006-11-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2017-03-31
Who can join
Age: 16 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Iowa — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.