Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants
Nahrungsergänzung Mit Cholin- Und Docosahexaensäure Bei Sehr Unreifen Frühgeborenen
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.
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Tuebingen、德国、72076
- University Hospital of Tuebingen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- preterm infants with a gestational age at birth between 24 and 32 weeks
- on almost complete enteral feeding (>75% of total fluid intake)
Exclusion Criteria:
- insufficient enteral intake,
- gastrointestinal disease,
- missing parental consent
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:standard nutrition
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standard nutrition
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实验性的:choline supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
|
standard nutrition
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
|
实验性的:DHA supplementation
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
|
standard nutrition
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
|
实验性的:choline and DHA supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride and 60mg/kg of DHA for 10 days
|
standard nutrition
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
plasma concentrations of choline
大体时间:following 7 days of supplementation
|
following 7 days of supplementation
|
次要结果测量
结果测量 |
大体时间 |
---|---|
de-novo DHA-phosphatidylcholine synthesis
大体时间:following 7 days of supplementation at 12hours after D9-choline administration
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following 7 days of supplementation at 12hours after D9-choline administration
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DHA-phosphatidylcholine turnover
大体时间:following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration
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following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration
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fractions and concentrations of molecular species of phosphatidylcholine
大体时间:baseline and following 7.5 and 10 days of supplementation
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baseline and following 7.5 and 10 days of supplementation
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plasma concentrations of choline
大体时间:baseline and following 7.5 and 10 days of supplementation
|
baseline and following 7.5 and 10 days of supplementation
|
Plasma concentrations of betaine (a metabolite of choline)
大体时间:baseline and following 7.5 and 10 days of supplementation
|
baseline and following 7.5 and 10 days of supplementation
|
Plasma concentrations of dimethylglycine (a metabolite of choline)
大体时间:baseline and following 7.5 and 10 days of supplementation
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baseline and following 7.5 and 10 days of supplementation
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Plasma concentrations of trimethylamineoxide (TMAO, a metabolite of choline)
大体时间:baseline and following 7.5 and 10 days of supplementation
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baseline and following 7.5 and 10 days of supplementation
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合作者和调查者
调查人员
- 首席研究员:Axel Franz, MD、University Hospital Tuebingen
出版物和有用的链接
一般刊物
- Bernhard W, Full A, Arand J, Maas C, Poets CF, Franz AR. Choline supply of preterm infants: assessment of dietary intake and pathophysiological considerations. Eur J Nutr. 2013 Apr;52(3):1269-78. doi: 10.1007/s00394-012-0438-x. Epub 2012 Sep 9.
- Bernhard W, Raith M, Kunze R, Koch V, Heni M, Maas C, Abele H, Poets CF, Franz AR. Choline concentrations are lower in postnatal plasma of preterm infants than in cord plasma. Eur J Nutr. 2015 Aug;54(5):733-41. doi: 10.1007/s00394-014-0751-7. Epub 2014 Aug 23.
- Bernhard W, Raith M, Koch V, Kunze R, Maas C, Abele H, Poets CF, Franz AR. Plasma phospholipids indicate impaired fatty acid homeostasis in preterm infants. Eur J Nutr. 2014 Oct;53(7):1533-47. doi: 10.1007/s00394-014-0658-3. Epub 2014 Jan 24.
- Bernhard W, Bockmann K, Maas C, Mathes M, Hovelmann J, Shunova A, Hund V, Schleicher E, Poets CF, Franz AR. Combined choline and DHA supplementation: a randomized controlled trial. Eur J Nutr. 2020 Mar;59(2):729-739. doi: 10.1007/s00394-019-01940-7. Epub 2019 Mar 11.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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