Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Changes in DNA Methylation patterns
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women (18+) with a prior pregnancy affected by spina bifida
- •Available for required study visits
排除标准
- •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.)
研究组 & 干预措施
Folic Acid
5 mg folic acid supplement by mouth once a day for 12 weeks
干预措施: Folic Acid Tablet (Dietary Supplement)
结局指标
主要结局
Changes in DNA Methylation patterns
时间窗: Week 1 and Week 12
The investigators will use DNA methylation arrays to compare methylation patterns before and after course of folic acid.
次要结局
- Changes in serum folate concentration(Week 1 and Week 12)
研究者
Maitreyi Mazumdar
Associate Professor of Neurology
Boston Children's Hospital