Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants
Nahrungsergänzung Mit Cholin- Und Docosahexaensäure Bei Sehr Unreifen Frühgeborenen
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.
Przegląd badań
Status
Warunki
Szczegółowy opis
In utero, there is a constant high supply of choline to the fetus. Preterm delivery disrupts this maternal-fetal choline-transfer. We have shown that choline plasma levels rapidly half after preterm delivery. We also demonstrated that plasma DHA-PC rapidly falls after preterm delivery. DHA supplementation has been evaluated and found safe, however the clinical benefits have been smaller than expected. We speculate that choline deficiency may have contributed to the smaller than expected benefit of DHA supplementation in the past.
This study verifies the hypothesis that concomitant supply of choline and DHA will improve DHA-PC availability and turn-over. This is important because DHA-PC is the transport molecule for the DHA transport to the brain and the retina.
To explore the effects of enteral choline and DHA supplementation on plasma choline and DHA-PC concentrations, 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 future larger studies evaluating this approach of enteral co-application of choline and DHA on important clinical outcomes.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Tuebingen, Niemcy, 72076
- University Hospital of Tuebingen
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- preterm infants with a gestational age at birth between 24 and 32 weeks
- on almost complete enteral feeding (>75% of total fluid intake)
Exclusion Criteria:
- insufficient enteral intake,
- gastrointestinal disease,
- missing parental consent
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: standard nutrition
|
standard nutrition
|
|
Eksperymentalny: choline supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
|
standard nutrition
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
|
|
Eksperymentalny: DHA supplementation
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
|
standard nutrition
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
|
|
Eksperymentalny: choline and DHA supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride and 60mg/kg of DHA for 10 days
|
standard nutrition
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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
plasma concentrations of choline
Ramy czasowe: following 7 days of supplementation
|
following 7 days of supplementation
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
de-novo DHA-phosphatidylcholine synthesis
Ramy czasowe: following 7 days of supplementation at 12hours after D9-choline administration
|
following 7 days of supplementation at 12hours after D9-choline administration
|
|
DHA-phosphatidylcholine turnover
Ramy czasowe: following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration
|
following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration
|
|
fractions and concentrations of molecular species of phosphatidylcholine
Ramy czasowe: baseline and following 7.5 and 10 days of supplementation
|
baseline and following 7.5 and 10 days of supplementation
|
|
plasma concentrations of choline
Ramy czasowe: baseline and following 7.5 and 10 days of supplementation
|
baseline and following 7.5 and 10 days of supplementation
|
|
Plasma concentrations of betaine (a metabolite of choline)
Ramy czasowe: baseline and following 7.5 and 10 days of supplementation
|
baseline and following 7.5 and 10 days of supplementation
|
|
Plasma concentrations of dimethylglycine (a metabolite of choline)
Ramy czasowe: baseline and following 7.5 and 10 days of supplementation
|
baseline and following 7.5 and 10 days of supplementation
|
|
Plasma concentrations of trimethylamineoxide (TMAO, a metabolite of choline)
Ramy czasowe: baseline and following 7.5 and 10 days of supplementation
|
baseline and following 7.5 and 10 days of supplementation
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Axel Franz, MD, University Hospital Tuebingen
Publikacje i pomocne linki
Publikacje ogólne
- Bernhard 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.
- 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.
- Bernhard 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.
- Bernhard 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Choline and DHA for Preemies 2
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .