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Completed

NCT Number: NCT02509728

Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants

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.

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Key information

Age range

1 week–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Tuebingen

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

choline supplementation

Dietary Supplement

in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days

DHA Supplementation

Dietary Supplement

in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days

standard nutrition

Dietary Supplement

standard nutrition

Primary outcomes

  1. plasma concentrations of choline

    Time frame: following 7 days of supplementation

Secondary outcomes

  1. de-novo DHA-phosphatidylcholine synthesis

    Time frame: following 7 days of supplementation at 12hours after D9-choline administration

  2. DHA-phosphatidylcholine turnover

    Time frame: following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration

  3. fractions and concentrations of molecular species of phosphatidylcholine

    Time frame: baseline and following 7.5 and 10 days of supplementation

  4. plasma concentrations of choline

    Time frame: baseline and following 7.5 and 10 days of supplementation

  5. Plasma concentrations of betaine (a metabolite of choline)

    Time frame: baseline and following 7.5 and 10 days of supplementation

  6. Plasma concentrations of dimethylglycine (a metabolite of choline)

    Time frame: baseline and following 7.5 and 10 days of supplementation

  7. Plasma concentrations of trimethylamineoxide (TMAO, a metabolite of choline)

    Time frame: baseline and following 7.5 and 10 days of supplementation

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Nahrungsergänzung Mit Cholin- Und Docosahexaensäure Bei Sehr Unreifen Frühgeborenen

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 28, 2015
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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