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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05944055
Acronym
25OHVDORBPDD
Enrollment
173
Registered
2023-07-13
Start date
2023-01-01
Completion date
2023-12-01
Last updated
2023-07-17

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

Conditions

Bronchopulmonary Dysplasia, Vitamin D Overdose

Keywords

vitamin D, Overdoses, Bronchopulmonary Dysplasia, Preterm infants

Brief 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.

Interventions

BIOLOGICALIs 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
23 Weeks to 31 Weeks
Healthy volunteers
No

Inclusion criteria

* Inclusion Criteria \* : * Infant born before 31 weeks of gestation. * hospitalized in the NICU during at least 10 days * with at least a 25OH-D determination available before 36 weeks corrected age

Exclusion criteria

-Infant with at least a 25OH-D below 50 nmol/L

Design outcomes

Primary

MeasureTime frameDescription
Bronchopulmonary dysplasia or deathThe outcome will be assessed at 36 weeks corrected age.Bronchopulmonary dysplasia is defined as any respiratory support or oxygen requirement at 36 weeks corrected age.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026