Increase and decrease of the concentration of choline derivates in the plasma of preterm infants after the administration of unlabeled choline supplements

Increase and decrease of the concentration of choline derivates in the plasma of preterm infants after the administration of unlabeled choline supplements - CHOLINORAL IId

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020505

Enrollment

Registered

2020-01-23

Start date

2022-06-17

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: Choline chloride (40mg/kg/d), blood samples at up to 72h before as well as 3 or 6h after start and 3 or 6h after end of administration for two days. Group 2: Choline bitartrate (72mg/kg/d), b

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 / birth weight 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 the choline plasma concentration 0h-54h	—

Secondary

Measure	Time frame
1. Change of plasma concentration of cholin between 3 and 54h 2. Change of plasma concentrations of metabolites between 3 and 54h	—

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