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

March 16, 2026 updated by: Maitreyi Mazumdar, Boston Children's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1207
        • National Institute of Neurosciences and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Folic Acid
5 mg folic acid supplement by mouth once a day for 12 weeks
Dietary supplement: Folic Acid Tablet
5 mg folic acid supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1 and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 1 and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

National Institute of Neurosciences and Hospital, Dhaka

Investigators

  • Principal Investigator: Maitreyi Mazumdar, MD, MPH, Boston Children's Hospital
  • Principal Investigator: Sudipta K Mukherjee, MBBS, MS, National Institute of Neurosciences and Hospital, Dhaka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2023

Primary Completion (Actual)

December 4, 2024

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (Actual)

August 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-P00043006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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