An interventional study of Folic Acid Tablet in Pregnancy; Spina Bifida, Fetal and Environmental Exposure, sponsored by Boston Children's Hospital. Completed at 1 site in Bangladesh. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Basic science
Folic acid is currently considered to be the standard of care for primary and secondary prevention of spina bifida, but the mechanisms underlying folic acid's benefits are unknown. One hypothesis is that folic acid changes DNA methylation and transcription of genes important in neural tube closure.
In this study, the investigators will evaluate how DNA methylation of genes associated with neural tube closure changes after a short course of standard-of-care folic acid supplementation. In addition, the investigators will assess whether environmental arsenic exposure modifies the effects of folic acid on the methylosome.
The investigators will encourage women who have recently had a pregnancy affected by spina bifida to take daily folic acid supplements for three months. Folic acid supplementation is considered standard of care for primary and secondary prevention of spina bifida. The investigators will compare DNA methylation in blood and folate levels before and after folic acid use.
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This study's enrollment of 69 is above the median of 30 across 91 interventional studies indexed under Spinal Dysraphism.
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Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
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Exclusion Criteria:
5 mg folic acid supplement by mouth once a day for 12 weeks
Dietary Supplement: Folic Acid Tablet
5 mg folic acid supplement
Changes in DNA Methylation patterns
The investigators will use DNA methylation arrays to compare methylation patterns before and after course of folic acid.
Time frame: Week 1 and Week 12
Changes in serum folate concentration
Chemiluminescent Microparticle Immunoassay will be used to measure folate concentration. The investigators will assess changes in serum folate concentration before and after folic acid use.
Time frame: Week 1 and Week 12
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Folic Acid