Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants
Nahrungsergänzung Mit Cholin- Und Docosahexaensäure Bei Sehr Unreifen Frühgeborenen
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 22, 2015
CompletedFirst Posted
Study publicly available on registry
July 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedMay 15, 2018
May 1, 2018
2.3 years
July 22, 2015
May 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
plasma concentrations of choline
following 7 days of supplementation
Secondary Outcomes (7)
de-novo DHA-phosphatidylcholine synthesis
following 7 days of supplementation at 12hours after D9-choline administration
DHA-phosphatidylcholine turnover
following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration
fractions and concentrations of molecular species of phosphatidylcholine
baseline and following 7.5 and 10 days of supplementation
plasma concentrations of choline
baseline and following 7.5 and 10 days of supplementation
Plasma concentrations of betaine (a metabolite of choline)
baseline and following 7.5 and 10 days of supplementation
- +2 more secondary outcomes
Study Arms (4)
standard nutrition
ACTIVE COMPARATORstandard nutrition
choline supplementation
EXPERIMENTALin addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
DHA supplementation
EXPERIMENTALin addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
choline and DHA supplementation
EXPERIMENTALin addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride and 60mg/kg of DHA for 10 days
Interventions
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
standard nutrition
Eligibility Criteria
You may qualify if:
- preterm infants with a gestational age at birth between 24 and 32 weeks
- on almost complete enteral feeding (\>75% of total fluid intake)
You may not qualify if:
- insufficient enteral intake,
- gastrointestinal disease,
- missing parental consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Tuebingen
Tübingen, 72076, Germany
Related Publications (4)
Bernhard W, Raith M, Kunze R, Koch V, Heni M, Maas C, Abele H, Poets CF, Franz AR. Choline concentrations are lower in postnatal plasma of preterm infants than in cord plasma. Eur J Nutr. 2015 Aug;54(5):733-41. doi: 10.1007/s00394-014-0751-7. Epub 2014 Aug 23.
PMID: 25148882BACKGROUNDBernhard W, Raith M, Koch V, Kunze R, Maas C, Abele H, Poets CF, Franz AR. Plasma phospholipids indicate impaired fatty acid homeostasis in preterm infants. Eur J Nutr. 2014 Oct;53(7):1533-47. doi: 10.1007/s00394-014-0658-3. Epub 2014 Jan 24.
PMID: 24464176BACKGROUNDBernhard W, Full A, Arand J, Maas C, Poets CF, Franz AR. Choline supply of preterm infants: assessment of dietary intake and pathophysiological considerations. Eur J Nutr. 2013 Apr;52(3):1269-78. doi: 10.1007/s00394-012-0438-x. Epub 2012 Sep 9.
PMID: 22961562BACKGROUNDBernhard W, Bockmann K, Maas C, Mathes M, Hovelmann J, Shunova A, Hund V, Schleicher E, Poets CF, Franz AR. Combined choline and DHA supplementation: a randomized controlled trial. Eur J Nutr. 2020 Mar;59(2):729-739. doi: 10.1007/s00394-019-01940-7. Epub 2019 Mar 11.
PMID: 30859363DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Axel Franz, MD
University Hospital Tuebingen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2015
First Posted
July 28, 2015
Study Start
July 1, 2015
Primary Completion
October 31, 2017
Study Completion
December 31, 2017
Last Updated
May 15, 2018
Record last verified: 2018-05