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

NCT05500690 | Completed

• 1 other identifier: IRB-P00043006
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Environmental Exposure; Pregnancy; Spina Bifida, Fetal

Keywords

Spina Bifida; Folic Acid; DNA Methylation; arsenic

Outcome Measures

Primary Outcomes (1)

• Changes in DNA Methylation patterns

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

  Week 1 and Week 12

Secondary Outcomes (1)

• Changes in serum folate concentration

  Week 1 and Week 12

Study Arms (1)

Folic Acid

EXPERIMENTAL

5 mg folic acid supplement by mouth once a day for 12 weeks

Dietary Supplement: Folic Acid Tablet

Interventions

Folic Acid Tablet DIETARY_SUPPLEMENT

5 mg folic acid supplement

Folic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women (18+) with a prior pregnancy affected by spina bifida
• Available for required study visits

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute of Neurosciences and Hospital, Dhaka: collaborator

Study Sites (1)

National Institute of Neurosciences and Hospital

Dhaka, 1207, Bangladesh

Location

MeSH Terms

Conditions

Spinal Dysraphism

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Maitreyi Mazumdar, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Sudipta K Mukherjee, MBBS, MS

  National Institute of Neurosciences and Hospital, Dhaka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 15, 2022
• Study Start: October 15, 2023
• Primary Completion: December 4, 2024
• Study Completion: December 1, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

BA (1)