EUCTR2011-003325-10-NL进行中（未招募）不适用
A randomized controlled trail on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth - Folic acid Extra
VU University Medical Center0 个研究点开始时间: 2012年8月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •All women living in the Northern region of the Netherlands of 18 to 45 years old who want to become pregnant within 12 months are eligible for participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
- •All women living in the Northern region of the Netherlands of 18 to 45 years old who want to become pregnant within 12 months are eligible for participation in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •When the participant appears to have a multiple pregnancy, she will be excluded for further participation, because these women are advised by midwifes to use 1 mg FA. Women who had previous offspring with NTD and other women who take high doses of FA for any other reason and women who use FA-antagonists will be excluded from the study.
- •Further exclusion criteria are:
- •a)no informed consent given
- •b)not understanding Dutch
- •c)already pregnant at time of inclusion or within 4 weeks after start intervention
- •d)planning to move to an area where the study is not implemented
- •e)recently or at present using folic acid antagonists or antifolates or other drugs influencing the folic acid metabolism (methotrexaat, pyrimethamine, trimethoprim)
- •f)being affected by epilepsy, diabetes, megaloblastic anaemia and/or cancer (previous cancer or abnormal PAP smears)
- •g)being allergic to folic acid or any other ingredient of the pills used in this study
- •h)take defined dosages of folic acid for directions other than those listed in the above exclusion criteria.
- •When the participant appears to have a multiple pregnancy, she will be excluded for further participation, because these women are advised by midwifes to use 1 mg FA. Women who had previous offspring with NTD and other women who take high doses of FA for any other reason and women who use FA-antagonists will be excluded from the study.
- •Further exclusion criteria are:
- •a)no informed consent given
- •b)not understanding Dutch
- •c)already pregnant at time of inclusion or within 4 weeks after start intervention
- •d)planning to move to an area where the study is not implemented
- •e)recently or at present using folic acid antagonists or antifolates or other drugs influencing the folic acid metabolism (methotrexaat, pyrimethamine, trimethoprim)
- •f)being affected by epilepsy, diabetes, megaloblastic anaemia and/or cancer (previous cancer or abnormal PAP smears)
- •g)being allergic to folic acid or any other ingredient of the pills used in this study
- •h)take defined dosages of folic acid for directions other than those listed in the above exclusion criteria.
研究者
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