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

NCT05500690 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-03-17

No results posted yet for this study

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.

Conditions

  • Pregnancy; Spina Bifida, Fetal
  • Environmental Exposure

Interventions

DIETARY_SUPPLEMENT

Folic Acid Tablet

5 mg folic acid supplement

Sponsors & Collaborators

Principal Investigators

  • Maitreyi Mazumdar, MD, MPH · Boston Children's Hospital

  • Sudipta K Mukherjee, MBBS, MS · National Institute of Neurosciences and Hospital, Dhaka

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2024-12-04
Completion
2025-12-01

Countries

  • Bangladesh

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05500690 on ClinicalTrials.gov