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

Not Applicable

Active, not recruiting

• Conditions: Environmental Exposure; Pregnancy; Spina Bifida, Fetal
• Interventions: Dietary Supplement: Folic Acid Tablet

• Registration Number: NCT05500690
• Lead Sponsor: Boston Children's Hospital

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.

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 Timeline

• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-15
• Study Start: 2023-10-15
• Primary Completion: 2024-12-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Folic Acid	Folic Acid Tablet	5 mg folic acid supplement by mouth once a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in DNA Methylation patterns	Week 1 and Week 12	The investigators will use DNA methylation arrays to compare methylation patterns before and after course of folic acid.

Secondary Outcome Measures

Name	Time	Method
Changes in serum folate concentration	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.

Trial Locations

Locations (1)

National Institute of Neurosciences and Hospital; 🇧🇩 Dhaka, Bangladesh