The Association Between Niacin Deficiency and Birth Defects: a Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7,500
- 试验地点
- 1
- 主要终点
- fetal outcomes
研究概览
简要总结
This prospective nested case-control study aims to examine the effects of blood vitamin B levels in first-trimester pregnant women on the pregnancy outcomes
详细描述
Folate deficiency can cause severe adverse pregnancy outcomes, such as neural tube defects. Effective folate functioning requires essential metabolic interactions with other B vitamins including vitamin B2, vitamin B3, vitamin B6, and vitamin B12, which can also influence pregnancy outcomes independently. For example, animal and family studies have identified that niacin (B3) deficiency can lead to congenital malformations. However, how folate and related B-vitamin levels interact with each other while affecting various pregnancy outcomes including abortion, birth defects, pregnancy complications, etc. is unclear. Besides, folate levels in previous studies were mostly measured in plasma which are easily influenced by dietary factors, instead of red blood cell folate which can reflect the long-term status. Moreover, the difference in the risk of neural tube defects across a range of maternal red blood cell folate concentrations has been largely ignored. Using data of pregnant women recruited at Beijing Obstetrics and Gynecology Hospital from December 2020 to December 2021, this case-control study aims to examine the association of folate and related B-vitamin levels in first-trimester blood samples (plasma and red blood cell) with pregnancy outcomes, particularly the association between niacin deficiency and birth defects.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with 6-13(+6 days) gestational weeks
- •Resided in Beijing in the past year
- •Pregnant women who intend to have antenatal examinations and delivery at Beijing Obstetrics and Gynecology Hospital
- •Pregnant women who are willing to participate in this study with informed consent
排除标准
- •Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.
结局指标
主要结局
fetal outcomes
时间窗: 42 days after delivery
Including birth defects
maternal outcomes
时间窗: at delivery
Including gestational hypertension, preeclampsia, gestational diabetes mellitus, hypothyroidism
次要结局
未报告次要终点
