Investigating the effects of vitamin D overdose on preterm infants
Is 25OHD Overdoses Before 36 Weeks Corrected Age an Independant Risk Factor of Bronchopulmonary Dysplasia or Death ?
This study looks at whether too much vitamin D can affect the health of preterm infants by increasing their risk of lung problems or death.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 173 (estimated) |
| Ages | 23 Weeks to 31 Weeks |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Trial ID | NCT05944055 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between vitamin D overdose and the risk of bronchopulmonary dysplasia or death in infants born before 31 weeks of gestation. It will include a retrospective cohort of preterm infants who were hospitalized in a neonatal intensive care unit for at least 10 days and had their vitamin D levels measured. The study will analyze the incidence of bronchopulmonary dysplasia and mortality in relation to vitamin D overdose, excluding those with vitamin D deficiency. The findings could provide insights into the safety of vitamin D supplementation in vulnerable populations.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born before 31 weeks of gestation who were hospitalized in a NICU for at least 10 days.
Not a fit: Patients with vitamin D levels below 50 nmol/L will not benefit from this study as they are excluded from participation.
Why it matters
Potential benefit: If successful, this study could help identify safe vitamin D supplementation practices for preterm infants, potentially reducing the risk of serious health complications.
How similar studies have performed: While there have been studies on vitamin D deficiency and bronchopulmonary dysplasia, this specific investigation into vitamin D overdose is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bron
- Hôpital Femme Mère Enfant — Bron, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.