NCT00894920已完成不适用
Biotin Status in Pregnancy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Lymphocyte propionyl-CoA carboxylase (PCC) activities
研究概览
简要总结
The purpose of this study is to estimate the number of pregnant women who, during pregnancy, have low levels of the vitamin biotin. The hypothesis of this study is that a large number of pregnant women will have low biotin levels. This information will be used to later determine if low biotin levels during pregnancy cause certain birth defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18-40
- •in early pregnancy (less than 15 weeks gestation)
- •under care of physician
- •normal pregnancy
- •taking prenatal vitamin with less than 30 mcg biotin
排除标准
- •prenatal vitamin with greater than 30 mcg biotin
- •antibiotic use
- •known renal disease
- •drug, alcohol abuse
- •gastric bypass
- •daily diet high in biotin
- •use of certain meal replacement products high in biotin
- •previous history of children with birth defects
结局指标
主要结局
Lymphocyte propionyl-CoA carboxylase (PCC) activities
时间窗: 2-3 months
次要结局
- Other biotin-related indicators in urine and blood(2-3 months)
- Urinary biotin excretion(2-3 months)
- Urinary 3-hydroxyisovaleric acid (3HIA) excretion(2-3 months)
研究者
研究点 (2)
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