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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard nutrition | Active Comparator | standard nutrition |
|
| choline supplementation | Experimental | in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days |
|
| DHA supplementation | Experimental | in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days |
|
| choline and DHA supplementation | Experimental | in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride and 60mg/kg of DHA for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| choline supplementation | Dietary Supplement | in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentrations of choline | following 7 days of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Axel Franz, MD | University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Tuebingen | Tübingen | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25148882 | Background | 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. | |
| 24464176 | Background | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| DHA supplementation | Dietary Supplement | in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days |
|
| standard nutrition | Dietary Supplement | standard nutrition |
|
| 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 |
| Plasma concentrations of dimethylglycine (a metabolite of choline) | baseline and following 7.5 and 10 days of supplementation |
| Plasma concentrations of trimethylamineoxide (TMAO, a metabolite of choline) | baseline and following 7.5 and 10 days of supplementation |
| 22961562 | Background | 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. |
| 30859363 | Derived | 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. |
| D000091642 | Urogenital Diseases |