Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06199102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-27
Brief Title:
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants
Sponsor:
Princess Anna Mazowiecka Hospital Warsaw Poland
Organization:
Princess Anna Mazowiecka Hospital Warsaw Poland
Study Overview
Official Title:
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants A Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIDVID
Brief Summary:
The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease
Detailed Description:
Vitamin D deficiency can escalate prematurity bone disease in preterm infants and negatively influence their immature immunology system Infants born at 2407 weeks to 3267 weeks of gestation will be considered for inclusion Cord or vein blood samples will be obtained within 48 h after birth for 25-hydroxyvitamin D level measurements Parathyroid hormone and interleukin-6 levels will be measured Infants will be randomized to the monitored group ie initial dose of 1000 IUday and possible modification or the controlled group ie 250 IUday or 500 IUday dose depending on weight Supplementation will be monitored up to postconceptional age 35 weeks The primary endpoint is the percentage of infants with deficient or suboptimal 25-hydroxyvitamin D levels at 282 days of age 25-Hydroxyvitamin D levels will be measured at postconceptional age 352 weeks Secondary objectives include the incidence of sepsis osteopenia hyperparathyroidism and elevated interleukin-6 concentration The aim of this study will be to assess the effectiveness of monitored vitamin D supplementation in a population of preterm infants and to determine whether a high initial dose of monitored vitamin D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None