Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants

May 9, 2018 updated by: University Hospital Tuebingen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • University Hospital of Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard nutrition
Dietary supplement: standard nutrition
standard nutrition
Experimental: choline supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
Dietary supplement: standard nutrition
standard nutrition
Dietary supplement: choline supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
Experimental: DHA supplementation
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
Dietary supplement: standard nutrition
standard nutrition
Dietary supplement: DHA supplementation
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
Experimental: choline and DHA supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride and 60mg/kg of DHA for 10 days
Dietary supplement: standard nutrition
standard nutrition
Dietary supplement: choline supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
Dietary supplement: DHA supplementation
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
plasma concentrations of choline
Time Frame: following 7 days of supplementation
following 7 days of supplementation

Secondary Outcome Measures

Outcome Measure
Time Frame
de-novo DHA-phosphatidylcholine synthesis
Time Frame: following 7 days of supplementation at 12hours after D9-choline administration
following 7 days of supplementation at 12hours after D9-choline administration
DHA-phosphatidylcholine turnover
Time Frame: following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration
following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration
fractions and concentrations of molecular species of phosphatidylcholine
Time Frame: baseline and following 7.5 and 10 days of supplementation
baseline and following 7.5 and 10 days of supplementation
plasma concentrations of choline
Time Frame: 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)
Time Frame: 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)
Time Frame: baseline and following 7.5 and 10 days of supplementation
baseline and following 7.5 and 10 days of supplementation
Plasma concentrations of trimethylamineoxide (TMAO, a metabolite of choline)
Time Frame: baseline and following 7.5 and 10 days of supplementation
baseline and following 7.5 and 10 days of supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Axel Franz, MD, University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Choline and DHA for Preemies 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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