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Completed

NCT Number: NCT05500690

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

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.

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Key information

Conditions

Pregnancy; Spina Bifida, Fetal Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Environmental Exposure Nervous System Diseases Nervous System Malformations Neural Tube Defects Spinal Dysraphism

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Neurosciences and Hospital

Dhaka, 1207, Bangladesh

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Folic Acid Tablet

Dietary Supplement

5 mg folic acid supplement

Primary outcomes

  1. Changes in DNA Methylation patterns

    Time frame: Week 1 and Week 12

    The investigators will use DNA methylation arrays to compare methylation patterns before and after course of folic acid.

Secondary outcomes

  1. Changes in serum folate concentration

    Time frame: Week 1 and Week 12

    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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • National Institute of Neurosciences and Hospital, Dhaka

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 15, 2022
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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