Goal: To provide new information on the use of folic acid in a large prospective clinical trial affecting children with cleft/craniofacial conditions.
Objective: Attendees will be able to identify risks, benefits, outcomes, and mechanisms of action in the clinical trial.
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RANDOMIZED CLINICAL TRIALS OF FOLIC ACID FOR PREVENTION OF RECURRENCES OF CLPJeffrey C. Murray, MD, George L. Wehby, PhD, Marie Tolarova, MD, PhD, DSc, John Canady, MD There have been a number of studies suggesting a possible beneficial effect of various doses of folic acid given to a mother preconceptionally to prevent recurrences of cleft lip and/or palate in her next pregnancy. Despite published reports and some recommendations on use there has been no definitive, prospective, randomized clinical trial of sufficient size to provide data on benefit and risk. A formal presentation providing background on folic acid and cleft recurrence and the current status of a large, randomized clinical trial in Brazil will be presented, as well as some options for including new sites and mechanisms of engagement and analysis. |
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