Trial document




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  DRKS00020505

Trial Description

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Title

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

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Trial Acronym

CHOLINORAL IId

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URL of the Trial

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Brief Summary in Lay Language

Comparison of the plasma kinetics of different choline components in adequate intake 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 different candidate substances of an optimized choline supplementation will be investigated in preterm infants. These candidates are physiologic organic choline esters (alpha-glycerophosphorylcholine [alpha-GPC] and egg phosphatidylcholine [PC]) in comparison with free choline salts (choline chloride, choline bitartrate). In plasma and erythrocyte membranes the concentrations of choline and its metabolites will be assessed to define differences of these components with respect to their plasma kinetics.

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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

  •   DRKS00020505
  •   2020/01/23
  •   [---]*
  •   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

  •   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.
  •   Choline bitartrate (72mg/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.
  •   alpha-GPC (73.5mg/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.
  •   Egg phosphatidylcholine (217mg/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.
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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 the choline plasma concentration 0h-54h

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Secondary Outcome

1. Change of plasma concentration of cholin between 3 and 54h
2. Change of plasma concentrations of metabolites between 3 and 54h

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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 / birth weight < 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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* This entry means the parameter is not applicable or has not been set.