CompletedNot Applicable

Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies

Bangladesh69 participantsStarted 2023-10-15

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion Criteria: * Women (18+) with a prior pregnancy affected by spina bifida * Available for required study visits Exclusion Criteria: * Personal history of diabetes or gestational diabetes * Current anticonvulsant medication use * History of pregnancy affected by identified genetic syndrome associated with neural tube defect such as Trisomy 18 * Current pregnancy * Abnormal peripheral blood film results (suggestive of megaloblastic anemia/B12 deficiency.)

What they're measuring

Changes in DNA Methylation patterns

Timeframe: Week 1 and Week 12

Trial details

NCT IDNCT05500690

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-04

View on ClinicalTrials.gov More Pregnancy; Spina Bifida, Fetal trials