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

Sponsor

Boston Children's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05500690

Collaborator

National Institute of Neurosciences and Hospital, Dhaka (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy; Spina Bifida, Fetal Environmental Exposure	Dietary Supplement: Folic Acid Tablet	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Neurosciences and Hospital	Dhaka		Bangladesh	1207

Sponsors and Collaborators

Boston Children's Hospital
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