Environmental Exposure Clinical Trial
Official title:
Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
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.
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.) |
Country | Name | City | State |
---|---|---|---|
Bangladesh | National Institute of Neurosciences and Hospital | Dhaka |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | National Institute of Neurosciences and Hospital, Dhaka |
Bangladesh,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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