Environmental Exposure, Pregnancy; Spina Bifida, Fetal
Conditions
Keywords
Spina Bifida, Folic Acid, DNA Methylation, arsenic
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.
Interventions
DIETARY_SUPPLEMENTFolic Acid Tablet
5 mg folic acid supplement
Sponsors
Boston Children's Hospital
National Institute of Neurosciences and Hospital, Dhaka
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 * Current pregnancy * Abnormal peripheral blood film results (suggestive of megaloblastic anemia/B12 deficiency.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Bangladesh
Contacts
PRINCIPAL_INVESTIGATORMaitreyi Mazumdar, MD, MPH
Boston Children's Hospital
PRINCIPAL_INVESTIGATORSudipta K Mukherjee, MBBS, MS
National Institute of Neurosciences and Hospital, Dhaka
Outcome results
None listed