Clinical trial No longer in our active list Interventional Ages 24 Hours to 96 Hours

Vitamin D supplementation for premature infants

Official title: Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight

Run by The University of Texas Health Science Center, Houston · NCT05459298 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study tests whether giving extra vitamin D to extremely premature infants can improve their health in areas like lung and bone development compared to standard care.

Quick facts

Study typeInterventional
Ages24 Hours to 96 Hours
SexAll
Enrollment180 (estimated)
SponsorThe University of Texas Health Science Center, Houston
Academic / other
Locations1 site (Houston, Texas)
Trial IDNCT05459298 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants born at less than 28 weeks gestational age or weighing less than 1000 grams.

Probably not a fit

Patients who are born at greater than 32 weeks gestational age or have major congenital anomalies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effects of vitamin D supplementation at 800 IU/day against usual care in extremely premature infants for the first 28 days after birth. It focuses on measuring vitamin D levels and assessing potential impacts on lung, bone, immune system, and brain function. The study will utilize intention-to-treat Bayesian analyses, along with Frequentist analyses, to evaluate the outcomes. The target population includes infants born at less than 28 weeks gestational age or weighing less than 1000 grams.

Why it matters

Potential benefit: If successful, this study could improve health outcomes for extremely premature infants by enhancing their vitamin D levels and potentially supporting better lung, bone, immune, and brain function.

How similar studies have gone: Other studies have explored vitamin D supplementation in premature infants, but this specific approach and population may offer novel insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Infants born at \< 28 weeks gestational age (GA) or \<1000 grams birth weight (BW)
* Inborn
* Informed written consent in an Institutional Review Board (IRB)-approved manner

Exclusion Criteria:

* GA \>32 weeks regardless of birth weight (BW)
* Any major congenital anomaly
* A known congenital nonbacterial infection
* Prenatal diagnosis of disorders that affect vitamin D absorption (e.g, cystic fibrosis)
* Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.

Where it's running

  • The University of Texas Health Science Center at Houston
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.