A study to help understand what forms of folic acid are most effective to increase folate status during pregnancy for the best protection against neural tube defects
A multisite randomized controlled trial to determine whether supplementation with (6S)-5-methyltetrahydrofolic acid (5-MTHF) is at least as effective as synthetic folic acid in increasing maternal folate status for protection against neural tube defects (NTDs).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
272
folic acid (0.6 mg)
0.625 mg/d (6S)-5-MTHF
RBC folate
•Maternal RBC folate concentrations (nmol/L)
Time frame: At 6 (± 2) wks gestation (approximate time of neural tube closure)
Maternal plasma placental growth factor (pg/mL)
A novel biomarker with increasing use in clinical practice due to a discriminatory capacity for fetal growth restriction vs a small, but healthy fetus
Time frame: At 18 (± 1) and 30 (± 1) wks gestation
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