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

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.

Conditions

• Vitamin D Deficiency
• Osteopenia of Prematurity
• Nephrolithiasis
• Metabolic Bone Disease
• Late-Onset Neonatal Sepsis

Interventions

DIETARY_SUPPLEMENT

cholecalciferol/ Devikap

Infants in the monitored group will receive an initial dose of 1000 IU of vit D. An additional 160 IU/kg of vit D is included in parenteral nutrition, as well as 150-300 IU/kg in enteral nutrition, depending on the amount and source of enteral feeding (i.e., human milk fortifiers or milk formula). At 28±2 days of age, blood samples will be obtained for 25(OH)D concentration measurement, followed by measurements every 4 weeks and/or 35±1 weeks of PCA. In the monitored group, vit D doses will be appropriately modified, based on 25(OH)D levels, using the scheme described in the Polish recommendation. The intake from the diet will be calculated from the second month of life.

DIETARY_SUPPLEMENT

cholecalciferol/ Devikap

Infants in the controlled group will receive 250 IU for very low birth weight infants and 500 IU for infants weighing above 1000 g. An additional 160 IU/kg of vit D is included in parenteral nutrition, as well as 150-300 IU/kg in enteral nutrition, depending on the amount and source of enteral feeding (i.e., human milk fortifiers or milk formula). Infants assigned to the standard therapy group will undergo the same blood sample collection procedure as the monitored group, but without any alterations in their dosing regimen.

Sponsors & Collaborators

• Medical University of Warsaw

  collaborator OTHER

• Princess Anna Mazowiecka Hospital, Warsaw, Poland

  lead OTHER

Principal Investigators

• Renata Bokiniec, MD, PhD · [email protected]

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

2 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-01

Primary Completion

2027-09-01

Completion

2027-12-31

Countries

• Poland

Study Locations