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

NANot yet recruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

September 1, 2027

Study Completion Date

December 31, 2027

Conditions
Vitamin D DeficiencyOsteopenia of PrematurityNephrolithiasisMetabolic Bone DiseaseLate-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.

Trial Locations (1)

00-315

Princess Anna Mazowiecka Hospital, Warsaw

All Listed Sponsors
collaborator

Medical University of Warsaw

OTHER

lead

Princess Anna Mazowiecka Hospital, Warsaw, Poland

OTHER