The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. (NCT06199102) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.
Poland130 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
1 Day – 2 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is looking at high initial doses of vitamin D in premature babies — given that it's listed as Phase NA and not yet recruiting, does my baby's care team have any insight into when it might open, and whether the dosing approach being studied differs from what my baby is already receiving in the NICU?
2The trial is monitoring for conditions like nephrolithiasis — which means kidney stones — as well as metabolic bone disease and late-onset sepsis: can you explain what risks a higher vitamin D dose might pose for my premature baby's kidneys and bones, and how those would be watched for?
3Since the study is measuring how many babies end up with deficient or suboptimal vitamin D levels, what is my baby's current 25(OH)D level, and how does the team decide whether the standard supplementation approach is already working or if something different might be worth considering?
4Because this trial isn't recruiting yet, is there a standard-of-care vitamin D supplementation protocol my baby's team is already following for premature infants, and how does it compare to what this study is trying to test?
5Given that my baby is premature and may be at risk for osteopenia of prematurity, are there other ongoing studies or established clinical approaches we should be discussing alongside this one before deciding whether to wait for this trial or pursue another path now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of infants with deficient or suboptimal 25(OH)D levels.
Timeframe: 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
Trial details
NCT IDNCT06199102
SponsorPrincess Anna Mazowiecka Hospital, Warsaw, Poland