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

Environmental Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500690
• Other study ID #: IRB-P00043006
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2023
• Est. completion date: November 2025

Study information

• Verified date: December 2023
• Source: Boston Children's Hospital
• Contact: Maitreyi Mazumdar, MD, MPH
• Phone: 617-355-2918
• Email: maitreyi.mazumdarmdmph[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Environmental Exposure
• Spinal Dysraphism

Intervention

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

Locations

Country	Name	City	State
Bangladesh	National Institute of Neurosciences and Hospital	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	National Institute of Neurosciences and Hospital, Dhaka

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in serum folate concentration	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