Before initiation of the FACT study, we cautiously
assessed the potential risk of daily supplementation with
4.0mg folic acid during pregnancy (for a duration of about
6 months) from the following four aspects: (1) short-term
effects, (2) long-term effects, (3) existing policy on folic acid
supplementation, and (4) health care provider support in
the obstetrical community through a survey of high risk
obstetricians in the country.
(1) Short-Term Effects. No adverse outcomes were observed
in women who took very high doses of folic acid in suicide
attempts [25]. No short-term adverse outcome associated
with folic acid supplementation in pregnancy at the recommended
dosage has been reported. In the proposed study,
most of the study visits for study participants will be integrated
with their routine prenatal care services.The physical
and emotional burden to the participants in the proposed
study is small.