Trial document




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  DRKS00020502

Trial Description

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Title

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

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Trial Acronym

CHOLINORAL IIc

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URL of the Trial

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Brief Summary in Lay Language

Comparison of the plasma kinetics of different D9-labeled choline components in tracer dosage in preterm infants

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Brief Summary in Scientific Language

To date clinical pilot studies on choline supplementation using choline chloride were performed in preterm infants and Cystic Fibrosis (CF) patients. In both patient groups this resulted in (1) a normalization of plasma choline concentrations, and in CF patients lung function was improved and increased liver fat reduced. (3.) In both groups, single labeling with D9-choline chloride resulted in a better understanding of choline and phospholipid metabolism. In this study the different candidates of optimized choline supplementation will be given to preterm infants, in form of a single oral tracer dosage of the D9-labeled analogues of organic esters (D9-alpha-glycerophosphorylcholine [D9-alpha-GPC], D9-phosphorylcholine and D9-phosphatidylcholine [D9-PC]), compared to the free D9-choline salt (D9-choline chloride). In plasma and erythrocyte membranes, D9-enrichment of choline and its deuterated metabolites will be determined over time, to assess differences in the intermediary metabolism of the individual components.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00020502
  •   2020/01/22
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  •   yes
  •   Approved
  •   322/2019B01, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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Health Condition or Problem studied

  •   E63.8 -  Other specified nutritional deficiencies
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Interventions/Observational Groups

  •   [D9-Methyl]-choline chloride (3.6mg/kg), blood samples at 6 and 48h or 12 and 60h (two blood samples per infant at clinically indicated time points)
  •   [D9-Methyl]-Phosphorylcholine chloride Ca-salt (6.4mg/kg), blood samples at 6 and 48h or 12 and 60h (two blood samples per infant at clinically indicated time points)
  •   [D9-Methyl]-alpha-GPC (6.4mg/kg), blood samples at 6 and 48h or 12 and 60h (two blood samples per infant at clinically indicated time points)
  •   [D9-Methyl]-POPC (18.6mg/kg), blood samples at 6 and 48h or 12 and 60h (two blood samples per infant at clinically indicated time points)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

AUC of D9-Betain

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/03/01
  •   32
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   40   Days
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Additional Inclusion Criteria

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

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Exclusion Criteria

1. Growth retardation / birthweight < 3rd percentile
2. genetic diseases
3. Diseases, that change the lipid metabolism, especially the gastro intestinum (i.e. stoma, exocrine pancreas insufficience, cholestase), systemic glucocorticoidtherapy, kidney insufficience (creatinine >1.5mg/dl), ventricular funcitonal limitations that influence the liver function
4. no informed consent of both parents

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Addresses

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    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Kinder- und Jugendheilkunde
    • Mr.  Prof.  Wolfgang  Bernhard 
    • Calwerstraße 7
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Kinder- und Jugendheilkunde
    • Mr.  Prof.  Wolfgang  Bernhard 
    • Calwerstraße 7
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Hipp-Werk Georg Hipp
    • Georg-Hipp-straße 7
    • 85276  Pfaffenhofen
    • Germany
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    •   +49(0)8441-757-129
    •   +49(0)8441-757-777-129
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    •   http://www.hipp.de
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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