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Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants

NCT02509728 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-05-15

No results posted yet for this study

Summary

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.

Conditions

  • Infant, Premature

Interventions

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

DIETARY_SUPPLEMENT

standard nutrition

standard nutrition

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Axel Franz, MD · University Hospital Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
2 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-10-31
Completion
2017-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02509728 on ClinicalTrials.gov