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

NCT ID: NCT05500690

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2025-11-30

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.

Conditions

Pregnancy; Spina Bifida, Fetal; Environmental Exposure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Folic Acid

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

Group Type: EXPERIMENTAL

Folic Acid Tablet

Intervention Type: DIETARY_SUPPLEMENT

5 mg folic acid supplement

Interventions

Folic Acid Tablet

5 mg folic acid supplement

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Neurosciences and Hospital, Dhaka

OTHER_GOV

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maitreyi Mazumdar

Associate Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maitreyi Mazumdar, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Sudipta K Mukherjee, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

National Institute of Neurosciences and Hospital, Dhaka

Locations

National Institute of Neurosciences and Hospital

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

IRB-P00043006

Identifier Type: -

Identifier Source: org_study_id