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Search / Trial NCT06199102

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

Launched by PRINCESS ANNA MAZOWIECKA HOSPITAL, WARSAW, POLAND · Jan 9, 2024

Trial Information

Current as of November 06, 2025

Not yet recruiting

Keywords

Vitamin D Preterm Infants Osteopenia Of Prematurity Late Onset Sepsis Metabolic Bone Disease

ClinConnect Summary

This clinical trial is looking at how effective a special vitamin D supplement is for preterm infants. Vitamin D is important for healthy bones and can help prevent certain health problems. The study aims to find out if giving preterm infants a monitored high dose of vitamin D can help reduce the chances of them getting infections, like neonatal sepsis, or developing metabolic bone disease, which affects how their bones grow.

To participate in the study, infants need to be born preterm, between 24 and 32 weeks of gestation, either at the clinic or admitted to the hospital shortly after birth. Caregivers must also agree to participate by signing a consent form. Unfortunately, infants born later than 32 weeks or those with serious health issues will not be eligible. While the trial is not yet recruiting participants, families can expect close monitoring during the study to ensure the safety and health of their infants while they receive this vitamin D supplement.

Gender

ALL

Eligibility criteria

  • 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

About Princess Anna Mazowiecka Hospital, Warsaw, Poland

The Princess Anna Mazowiecka Hospital in Warsaw, Poland, is a prominent healthcare institution dedicated to providing high-quality medical services and advancing clinical research. As a clinical trial sponsor, the hospital plays a pivotal role in the development of innovative therapies and treatments, facilitating research that adheres to rigorous ethical standards and regulatory requirements. With a multidisciplinary team of experienced professionals and a commitment to patient safety, the hospital fosters collaboration with academic institutions and industry partners, contributing to the advancement of medical science and improving patient outcomes.

Locations

Warsaw, Poland

Patients applied

0 patients applied

Trial Officials

Renata Bokiniec, MD, PhD

Study Chair

renata.bokiniec@wum.edu.pl

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported