While cleft lip/palate remains one of the most common birth defects, the medical community has fallen short on a well-designed clinical trial aimed at prevention. The most common reasons for an infant to acquire an oral cleft disorder includes inheritance, environmental factors, genetics, and lack of prenatal cares. The University of Iowa has designed a randomized double-controlled study to evaluate the effects of folic acid in women with a high risk for having an infant with an oral cleft lip and/or palate. Women are classified in this study as high risk if either they or their child has had an oral cleft defect at birth.
This study will include up to 6,000 subjects where they will receive either 0.4 mg or 4 mg of folic acid per day both before conception and to be continued during the first 3 months of their pregnancy, which is a critical developmental stage for an oral defect. Folic acid has previously been well-defined in its role with neural tube defects and there are several observational studies that have shown promise in folic acid and other vitamins in the role of preventing oral cleft disorders. However, this will be the first sufficiently powered study to help determine preventive effects of folic acid in a high risk population.
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