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Effects of prolonged choline supplementation on DNA-methylation and fat-free body mass in very preterm infants - pilot study with a dietary supplement

Effects of prolonged choline supplementation on DNA-methylation and fat-free body mass in very preterm infants - pilot study with a dietary supplement - Pro-Cholin

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038862
Enrollment
60
Registered
2026-02-04
Start date
2026-02-04
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrient deficiency in preterm infants

Interventions

Group 1: 20 preterm infants (28 0/7- 31 6/7 weeks at birth) with choline-supplementation. Infants receive supplemental choline (30mg/kg/d as glycerophosphocholine) when oral feedings >100ml/kg/d are e

Sponsors

Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Neonatologie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Group 1 - Preterm infants 28 0/7 - 31 6/7 gestational weeks - Group 2 - Term-born infants >37 0/7 gestational weeks - In case of multiple births: Only firstborn infant can be included, intervention in siblings possible if desired by the parents

Exclusion criteria

Exclusion criteria: • Malformations • Syndromal diseases • Metabolic diseases • SGA-growth (5mg/dl during the 1st week after birth • Circulatory support (hydrocortisone or catecholamine therapy) in the first week after birth • Gestational diabetes (with hypertrophy (>P90) or recurrent hypoglycaemia in the first days of life) • Gastrointestinal complications (e.g. intestinal perforation) or incomplete transition to full enteral feeding until/at day 14 after birth • Mother not willing to participate as associate

Design outcomes

Primary

MeasureTime frame
Degree of methylation of DNA at PMA 36-38 weeks after preterm delivery with and without choline supplementation (methyl-group-donor) compared to healthy term born infants as 0-100% methylated Guanosin-Bases

Secondary

MeasureTime frame
- Choline plasma concentration at PMA 36-38 weeks - Betaine and PC plasma concentrations at PMA 36-38 weeks - Fat mass and proportion of fat mass of total body mass at PMA 36-38 weeks

Countries

Germany

Contacts

Public ContactAxel R. Franz

Universitätsklinikum für Kinder- und Jugendmedizin Tübingen, Neonatologie

axel.franz@med.uni-tuebingen.de07071 29 82621

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026