Clinical trial NCT06199102: The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
Official title: The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vitamin D Deficiency
Osteopenia of Prematurity
Nephrolithiasis
Metabolic Bone Disease
Late-Onset Neonatal Sepsis
Keywords: vitamin D
preterm infants
osteopenia of prematurity
late-onset sepsis
metabolic bone disease
Lead sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Medical University of Warsaw
First posted: 2024-01-10
Enrollment: 130
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 24+0/7 weeks to 32+6/7 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 (i.e., initial dose of 1000 IU/day and possible modification) or the controlled group (i.e., 250 IU/day or 500 IU/day 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 28±2 days of age. 25-Hydroxyvitamin D levels will be measured at postconceptional age 35±2 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.

Eligibility criteria: Inclusion Criteria:

* preterm infants with a gestational age of 24+0/7 to 32+6/7 born at our clinic
* preterm infants with a gestational age of 24+0/7 to 32+6/7 outborn and admitted to our intensive care unit within 48h after delivery
* written informed consent form caregivers for the mother and the child to participate in the study

Exclusion Criteria:

* infants born at \>32 weeks of gestation
* infants with major congenital abnormalities or other severe congenital malformations
* infants with genetic disorders (diagnosed before and after birth) deemed incompatible with survival
* infants with diagnosed cholestasis
* the absence of written informed consent and challenges in communication with caregivers

Primary outcomes:
measure: The number of infants with deficient or suboptimal 25(OH)D levels.
timeFrame: at 28±2 days of age, after that every 4 weeks (number of measurements depends on gestation age at birth) and/ or at 35±1 weeks of postconceptional age
Secondary outcomes:
measure: The number of infants with neonatal late-onset sepsis.
timeFrame: after 3 days of age
measure: The number of infants with biochemical markers of metabolic bone disease.
timeFrame: at 35±1 weeks of postconceptional age
measure: The number of infants with hyperparathyroidism.
timeFrame: at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age
measure: The number of infants with high interleukin-6 levels.
timeFrame: at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age
measure: The number of infants with nephrocalcinosis and nephrolithiasis.
timeFrame: at 28±2 days of life and at 35±1 weeks of postconceptional age
measure: The number of infants with potentially toxic 25(OH)D levels.
timeFrame: at 28±2 days of age, after that every 4 weeks (number of measurements depends on gestation age at birth) and/ or at 35±1 weeks of postconceptional age
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Princess Anna Mazowiecka Hospital
Study officials:
affiliation: renata.bokiniec@wum.edu.pl
name: Renata Bokiniec, MD, PhD
role: STUDY_CHAIR
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