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| Name | Class |
|---|---|
| National Institute of Neurosciences and Hospital, Dhaka | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Folic Acid | Experimental | 5 mg folic acid supplement by mouth once a day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic Acid Tablet | Dietary Supplement | 5 mg folic acid supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maitreyi Mazumdar, MD, MPH | Boston Children's Hospital | Principal Investigator |
| Sudipta K Mukherjee, MBBS, MS | National Institute of Neurosciences and Hospital, Dhaka | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Neurosciences and Hospital | Dhaka | 1207 | Bangladesh |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 15, 2026 | |
| Reset | May 5, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 15, 2026 | May 5, 2026 |
| ID | Term |
|---|---|
| D016135 | Spinal Dysraphism |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 | Heterocyclic Compounds |