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

Princess Anna Mazowiecka Hospital, Warsaw, Poland

Status: Not yet enrolling

Conditions: Metabolic Bone Disease; Vitamin D Deficiency; Late-Onset Neonatal Sepsis; Nephrolithiasis; Osteopenia of Prematurity

Treatments: Dietary Supplement: cholecalciferol/ Devikap

Study type: Interventional

Funder types: Other

Identifiers

NCT06199102

VitD-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 1 to 2 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

monitored group

Experimental group

Description:

Infants in the monitored group will receive an initial dose of 1000 IU of vit D (cholecalciferol/ Devikap; Polpharma, Starogard Gdański, Poland).

Treatment:

Dietary Supplement: cholecalciferol/ Devikap

Dietary Supplement: cholecalciferol/ Devikap

controlled group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: cholecalciferol/ Devikap

Dietary Supplement: cholecalciferol/ Devikap