NCT02509728

Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants

Nahrungsergänzung Mit Cholin- Und Docosahexaensäure Bei Sehr Unreifen Frühgeborenen

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 1 Week – 2 Months
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Infant, Premature

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-10-31
• Completion: 2017-12-31
• First posted: 2015-07-28
• Last updated: 2018-05-15

Locations

1 site across 1 country: Germany