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临床试验/NCT01231646
NCT01231646已完成不适用

Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

Northwell Health1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Levels of Folate Receptor Autoantibodies

研究概览

简要总结

Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth to infant with certain birth defects. However, some medications may affect the action of folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how folate works in our body.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women ages 18-50 years inclusive who are taking valproate or lamotrigine for neurologic or psychiatric conditions
  • Valproate of lamotrigine must be used as monotherapy at stable doses for 6 weeks prior to the study for the neurologic or psychiatric illness; medications taken for other reasons are not excluded.

排除标准

  • Women with prior exposure to valproate or lamotrigine if they are taking lamotrigine or valproate respectively.

结局指标

主要结局

Levels of Folate Receptor Autoantibodies

时间窗: On the same day after informed consent was obtained

ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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