跳至主要内容
临床试验/NCT05073978
NCT05073978已完成不适用

The Association Between Niacin Deficiency and Birth Defects: a Case-control Study

Westlake University1 个研究点 分布在 1 个国家目标入组 7,500 人开始时间: 2020年12月1日最近更新:
适应症

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

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

研究者

发起方
Westlake University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

B-vitamin Levels and Adverse Pregnancy Outcomes | 临床试验