NCT05500690

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Pregnancy; Spina Bifida, Fetal
• Environmental Exposure

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Folic Acid Tablet	5 mg folic acid supplement

Timeline

• Start date: 2023-10-15
• Primary completion: 2024-12-04
• Completion: 2025-12-01
• First posted: 2022-08-15
• Last updated: 2026-03-17

Locations

1 site across 1 country: Bangladesh