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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tuebingen, Alemania, 72076
- University Hospital of Tuebingen
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: standard nutrition
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standard nutrition
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Experimental: choline supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
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standard nutrition
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
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Experimental: DHA supplementation
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
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standard nutrition
in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
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Experimental: choline and DHA supplementation
in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride and 60mg/kg of DHA for 10 days
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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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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plasma concentrations of choline
Periodo de tiempo: following 7 days of supplementation
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following 7 days of supplementation
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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de-novo DHA-phosphatidylcholine synthesis
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 betaine (a metabolite of choline)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Axel Franz, MD, University Hospital Tuebingen
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Choline and DHA for Preemies 2
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