Research paper
High Dosage Folic Acid Supplementation, Oral Cleft Recurrence and Fetal Growth
Study answer
What this study found
High-dose folic acid did not show added benefit over 0.4 mg for preventing isolated oral cleft recurrence. Recurrence was 2.5% in the 4 mg group and 2.9% in the 0.4 mg group (one-sided Fisher exact test p = 0.59), while both groups were below historical recurrence estimates of 6.8% and 6.3%. There were no significant differences in birth weight, gestational age, length, head circumference, Apgar scores, preeclampsia, or adverse events. Serum and red cell folate levels were higher with 4 mg, but the higher biomarker response did not translate into better clinical outcomes.
- Study & population
- Randomized interventional study conducted at six craniofacial clinics in Brazil.
- Intervention
- Oral folic acid was given as a single daily pill, either 0.4 mg or 4 mg, manufactured for the study.
- Key limitation
- The trial was underpowered to detect smaller differences in recurrence between 4 mg and 0.4 mg folic acid.
View source
Open PDFOriginal abstract
Objectives: To evaluate the effects of folic acid supplementation on isolated oral cleft recurrence and fetal growth. Patients and Methods: The study included 2,508 women who were at-risk for oral cleft recurrence and randomized into two folic acid s…