Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants

University Hospital Tuebingen

Status: Completed

Conditions: Infant, Premature

Treatments: Dietary Supplement: DHA supplementation; Dietary Supplement: standard nutrition; Dietary Supplement: choline supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02509728

Choline and DHA for Preemies 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 1 week to 2 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 4 patient groups

standard nutrition

Active Comparator group

Description:

standard nutrition

Treatment:

Dietary Supplement: standard nutrition

choline supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: standard nutrition

Dietary Supplement: choline supplementation

DHA supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: standard nutrition

Dietary Supplement: DHA supplementation

choline and DHA supplementation

Experimental group

Description:

in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride and 60mg/kg of DHA for 10 days

Treatment:

Dietary Supplement: standard nutrition

Dietary Supplement: choline supplementation

Dietary Supplement: DHA supplementation