Nahrungsergänzung Mit Cholin- Und Docosahexaensäure Bei Sehr Unreifen Frühgeborenen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- plasma concentrations of choline
研究概览
简要总结
To explore the effects of enteral choline and DHA supplementation on plasma choline and DHA-PC concentrations and metabolism, this randomized controlled study will assign 40 preterm infants to 1 of 4 groups: standard care, choline supplementation, DHA supplementation, and choline and DHA supplementation.
After 7 days of supplementation, a single dose of stable isotope labelled choline will be administered and the kinetics of newly synthesized DHA-PC determined to assess plasma levels, uptake and distribution of choline and DHA.
This study is designed to inform larger studies evaluating this approach of enteral co-application of choline and DHA on clinical important outcomes.
详细描述
In utero, there is a constant high supply of choline to the fetus. Preterm delivery disrupts this maternal-fetal choline-transfer. We have shown that choline plasma levels rapidly half after preterm delivery. We also demonstrated that plasma DHA-PC rapidly falls after preterm delivery. DHA supplementation has been evaluated and found safe, however the clinical benefits have been smaller than expected. We speculate that choline deficiency may have contributed to the smaller than expected benefit of DHA supplementation in the past.
This study verifies the hypothesis that concomitant supply of choline and DHA will improve DHA-PC availability and turn-over. This is important because DHA-PC is the transport molecule for the DHA transport to the brain and the retina.
To explore the effects of enteral choline and DHA supplementation on plasma choline and DHA-PC concentrations, this randomized controlled study will assign 40 preterm infants to 1 of 4 groups: standard care, choline supplementation, DHA supplementation, and choline and DHA supplementation.
After 7 days of supplementation, a single dose of stable isotope labelled choline will be administered and the kinetics of newly synthesized DHA-PC determined to assess plasma levels, uptake and distribution of choline and DHA.
This study is designed to inform future larger studies evaluating this approach of enteral co-application of choline and DHA on important clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Week 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants with a gestational age at birth between 24 and 32 weeks
- •on almost complete enteral feeding (>75% of total fluid intake)
排除标准
- •insufficient enteral intake,
- •gastrointestinal disease,
- •missing parental consent
研究组 & 干预措施
standard nutrition
standard nutrition
干预措施: standard nutrition (Dietary Supplement)
choline supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
干预措施: standard nutrition (Dietary Supplement)
DHA supplementation
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
干预措施: DHA supplementation (Dietary Supplement)
DHA supplementation
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
干预措施: standard nutrition (Dietary Supplement)
choline and DHA supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride and 60mg/kg of DHA for 10 days
干预措施: DHA supplementation (Dietary Supplement)
choline and DHA supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride and 60mg/kg of DHA for 10 days
干预措施: standard nutrition (Dietary Supplement)
choline supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
干预措施: choline supplementation (Dietary Supplement)
choline and DHA supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride and 60mg/kg of DHA for 10 days
干预措施: choline supplementation (Dietary Supplement)
结局指标
主要结局
plasma concentrations of choline
时间窗: following 7 days of supplementation
次要结局
- Plasma concentrations of betaine (a metabolite of choline)(baseline and following 7.5 and 10 days of supplementation)
- de-novo DHA-phosphatidylcholine synthesis(following 7 days of supplementation at 12hours after D9-choline administration)
- DHA-phosphatidylcholine turnover(following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration)
- Plasma concentrations of dimethylglycine (a metabolite of choline)(baseline and following 7.5 and 10 days of supplementation)
- plasma concentrations of choline(baseline and following 7.5 and 10 days of supplementation)
- Plasma concentrations of trimethylamineoxide (TMAO, a metabolite of choline)(baseline and following 7.5 and 10 days of supplementation)
- fractions and concentrations of molecular species of phosphatidylcholine(baseline and following 7.5 and 10 days of supplementation)