The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.

Not Applicable

Not yet recruiting

• Conditions: Late-Onset Neonatal Sepsis; Vitamin D Deficiency; Osteopenia of Prematurity; Nephrolithiasis; Metabolic Bone Disease
• Interventions: Dietary Supplement: cholecalciferol/ Devikap

• Registration Number: NCT06199102
• Lead Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland

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 Timeline

• Study First Submitted: 2023-12-27
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10
• Study Start: 2024-09-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controlled group	cholecalciferol/ Devikap	Infants in the controlled group will receive 250 IU (cholecalciferol/ Devikap; Polpharma, Starogard Gdański, Poland) for very low birth weight infants and 500 IU (cholecalciferol/ Devikap; Polpharma, Starogard Gdański, Poland) for infants weighing above 1000 g.
monitored group	cholecalciferol/ Devikap	Infants in the monitored group will receive an initial dose of 1000 IU of vit D (cholecalciferol/ Devikap; Polpharma, Starogard Gdański, Poland).

Primary Outcome Measures

Name	Time	Method
The number of infants with deficient or suboptimal 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	25-hydroxyvitamin D serum level below 30ng/ml

Secondary Outcome Measures

Name	Time	Method
The number of infants with biochemical markers of metabolic bone disease.	at 35±1 weeks of postconceptional age	serum levels of alkaline phosphatase \>500 IU and serum phosphate \<1.8 mmol/L
The number of infants with hyperparathyroidism.	at birth, at 28±2 days of life, and at 35±1 weeks of postconceptional age	serum or plasma concentration of PTH in infants should be 10-40 pg/mL
The number of infants with neonatal late-onset sepsis.	after 3 days of age	blood culture-proven (one blood sample of at least 1 mL) and/or clinical sepsis occurring 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 reference interval is calculated as 44 pg/mL; it is released within 2 h after the onset of bacteremia, peaks at approximately 6 h, and finally declines over the following 24 h
The number of infants with nephrocalcinosis and nephrolithiasis.	at 28±2 days of life and at 35±1 weeks of postconceptional age	venous samples for serum and urine calcium, and creatinine level measurements
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	25-hydroxyvitamin D serum level exceeding 100 ng/mL

Trial Locations

Locations (1)

Princess Anna Mazowiecka Hospital; 🇵🇱 Warsaw, Poland