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2012年8月10日
相关药物folic acid
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- VU University Medical Center
- 状态
- 进行中（未招募）
- 最后更新
- 13年前
概览
简要总结
暂无简介。
研究者
入排标准
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:
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.
结局指标
主要结局
未指定
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