- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02509728
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Tuebingen, Allemagne, 72076
- University Hospital of Tuebingen
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: standard nutrition
|
standard nutrition
|
Expérimental: 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
|
Expérimental: 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
|
Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
plasma concentrations of choline
Délai: following 7 days of supplementation
|
following 7 days of supplementation
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
de-novo DHA-phosphatidylcholine synthesis
Délai: following 7 days of supplementation at 12hours after D9-choline administration
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following 7 days of supplementation at 12hours after D9-choline administration
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DHA-phosphatidylcholine turnover
Délai: following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration
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following 7.5 days of supplementation, from 12hours to 60 hours after D9-choline administration
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fractions and concentrations of molecular species of phosphatidylcholine
Délai: baseline and following 7.5 and 10 days of supplementation
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baseline and following 7.5 and 10 days of supplementation
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plasma concentrations of choline
Délai: baseline and following 7.5 and 10 days of supplementation
|
baseline and following 7.5 and 10 days of supplementation
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Plasma concentrations of betaine (a metabolite of choline)
Délai: baseline and following 7.5 and 10 days of supplementation
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baseline and following 7.5 and 10 days of supplementation
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Plasma concentrations of dimethylglycine (a metabolite of choline)
Délai: baseline and following 7.5 and 10 days of supplementation
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baseline and following 7.5 and 10 days of supplementation
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Plasma concentrations of trimethylamineoxide (TMAO, a metabolite of choline)
Délai: baseline and following 7.5 and 10 days of supplementation
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baseline and following 7.5 and 10 days of supplementation
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Axel Franz, MD, University Hospital Tuebingen
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Choline and DHA for Preemies 2
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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