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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2024

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.

Interventions

  • Dietary Supplement: Folic Acid Tablet
    • 5 mg folic acid supplement

Arms, Groups and Cohorts

  • Experimental: Folic Acid
    • 5 mg folic acid supplement by mouth once a day for 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boston Children’s Hospital
  • Collaborator
    • National Institute of Neurosciences and Hospital, Dhaka
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maitreyi Mazumdar, Associate Professor of Neurology – Boston Children’s Hospital
  • Overall Official(s)
    • Maitreyi Mazumdar, MD, MPH, Principal Investigator, Boston Children’s Hospital
    • Sudipta K Mukherjee, MBBS, MS, Principal Investigator, National Institute of Neurosciences and Hospital, Dhaka
  • Overall Contact(s)
    • Maitreyi Mazumdar, MD, MPH, 617-355-2918, maitreyi.mazumdarmdmph@childrens.harvard.edu

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