Plasma kinetic of the concentration of D9-choline derivates in the plasma of preterm infants after administration of four D9-labeled choline supplements

Plasma kinetic of the concentration of D9-choline derivates in the plasma of preterm infants after administration of four D9-labeled choline supplements - CHOLINORAL IIc

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020502

Enrollment

Registered

2020-01-22

Start date

2021-01-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E63.8

Interventions

Group 1: [D9-Methyl]-choline chloride (3.6mg/kg), blood samples at 1 and 24h or 12 and 60h (two blood samples per infant at clinically indicated time points) Group 2: [D9-Methyl]-Phosphorylcholine chl

Eligibility

Sex/Gender

All

Age

No minimum to 40 Days

Inclusion criteria

Inclusion criteria: 1. Gestational age at birth 28-32 weeks 2. full enteral feeding 3. no acute diseases

Exclusion criteria

Exclusion criteria: 1. Growth retardation / birthweight 1.5mg/dl), ventricular funcitonal limitations that influence the liver function 4. no informed consent of both parents

Design outcomes

Primary

Measure	Time frame
AUC of D9-Enrichment of PC (normalized for a mean overall-PC-concentration)	—

Secondary

Measure	Time frame
1. Maximum of the plasma concentation of D9-Betain 2. Maximum of the plasma concentation of D9-PC 3. Distribution of the labeling to the different D9-choline labeled metabolites	—

Countries

Germany

Contacts

Public ContactWolfgang Bernhard

Universitätsklinik für Kinder- und Jugendheilkunde

wolfgang.bernhard@med.uni-tuebingen.de07071-2986377

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026