Does Folinic Acid Supplementation Decrease Homocysteine Concentrations in Newborns
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- lowering total homocysteine concentrations
研究概览
简要总结
The purpose of this study is to determine whether supplementation with folinic acid, a B vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine concentrations are associated with an increased risk of cerebrovascular accidents in adult, children and newborns. These increased concentrations can easily and safely be lowered by folic acid in adults.
详细描述
The incidence of cerebrovascular accidents (CVA) occurring perinatally is relatively high and aspects of the multifactorial pathophysiology remain unclear. Elevated homocysteine concentrations are shown to be associated with an increased risk for CVA in newborns. We want to study the possible homocysteine lowering effect of folinic acid in newborns.
We will include newborns in our prospective randomized folinic acid intervention study from patients admitted to our Neonatal Intensive Care Unit. We will measure total homocysteine (tHcy) and folate concentrations at three time points. The intervention group will be treated with folinic acid (70 µg/kg/day) for two weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •admitted at our NICU
排除标准
- •midline defects
- •Extracorporeal membrane oxygenation (ECMO) treatment
- •blood transfusion
- •overt renal failure
研究组 & 干预措施
folinic acid
Folinic acid was given for two weeks as 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv). This solution was administered either intravenously (first week) or orally. To lower homocysteine in adults 5 mg/day folic acid is frequently used. Using an average bodyweight of 70 kg for adults we calculated a daily dose of 70 microgram/kg/day for our newborns
干预措施: 5-formyltetrahydrofolate (10 mg/ml) (Pharmachemie bv) (Drug)
结局指标
主要结局
lowering total homocysteine concentrations
时间窗: 2 weeks
次要结局
未报告次要终点