The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. A Randomized Controlled Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 130
- Locations
- 2
- Primary Endpoint
- The number of infants with deficient or suboptimal 25(OH)D levels.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 2 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
The number of infants with deficient or suboptimal 25(OH)D levels.
Time Frame: 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
25-hydroxyvitamin D serum level below 30ng/ml
Secondary Outcomes
- The number of infants with biochemical markers of metabolic bone disease.(at 35±1 weeks of postconceptional age)
- The number of infants with hyperparathyroidism.(at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age)
- The number of infants with neonatal late-onset sepsis.(after 3 days of age)
- The number of infants with high interleukin-6 levels.(at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age)
- The number of infants with nephrocalcinosis and nephrolithiasis.(at 28±2 days of life and at 35±1 weeks of postconceptional age)
- The number of infants with potentially toxic 25(OH)D levels.(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)
Investigators
Alicja Kołodziejczyk
MD, PhD
Princess Anna Mazowiecka Hospital, Warsaw, Poland