NCT05944055

25OH Vitamin D Overdoses and Risk of Bronchopulmonary Dysplasia or Death

Is 25OHD Overdoses Before 36 Weeks Corrected Age an Independant Risk Factor of Bronchopulmonary Dysplasia or Death ?

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 173 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 23 Weeks – 31 Weeks
• Healthy volunteers: Not accepted

Summary

Several studies have demonstrated that vitamin D deficiency at birth is a risk factor of bronchopulmonary dysplasia. However, in an animal model of bronchopulmonary dysplasia vitamin D overdose has also been associated with an increased mortality and an increased lung injury. Such vitamin D overdose has been frequently reported in hospitalized neonates receiving the current supplementation. The hypothesis is that vitamin D overdose is an independent risk factor of bronchopulmonary dysplasia or death among infants born below 31 weeks gestational age excluding infants with vitamin D deficiency. This retrospective cohort study will include all infants born before 31 weeks of gestation (WG), who were hospitalized in a tertiary neonatal intensive care unit (NICU) during at least 10 days, for who at least one 25OH vitamin D determination was performed before 36 WG corrected age and whose parents are not opposed to the study. A descriptive analysis of the cohort depending on the occurrence of vitamin D overdose will be performed. A multivariate analysis will determine if vitamin D overdose is an independent risk factor of bronchopulmonary dysplasia or death among preterm infants, adjusting on the covariates known to be associated with bronchopulmonary dysplasia.

Conditions

• Bronchopulmonary Dysplasia
• Vitamin D Overdose

Interventions

Type	Name	Description
BIOLOGICAL	Is 25 OH vitamin D overdose a risk factor of bronchopulmonary dysplasia or death ?	Vitamin D overdose is frequent among preterm infants receiving the current supplementation (Mauras 2022, Kołodziejczyk-Nowotarska 2021). In our NICU, the protocol was to daily administrate 55 UI vitamin D during parenteral nutrition then 1000 UI during enteral nutrition for babies weighing more than 1000 g and 1200UI during enteral nutrition for babies weighing less than 1000 g. The dosage was adapted each month after a plasmatic measure of 25OH-D in order to maintain 25OH-D between 50 nmol/L and 120 nmol/L.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2023-07-13
• Last updated: 2023-07-17

Locations

1 site across 1 country: France