Vitamin D supplementation for premature infants
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
NA · The University of Texas Health Science Center, Houston · NCT05459298
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 24 Hours to 96 Hours |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05459298 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at less than 28 weeks gestational age or weighing less than 1000 grams.
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.
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 performed: Other studies have explored vitamin D supplementation in premature infants, but this specific approach and population may offer novel insights.
Eligibility criteria
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 this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Maria del Mar Romero López, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Maria del Mar Romero López, MD
- Email: Maria.del.Mar.RomeroLopez@uth.tmc.edu
- Phone: 713-500-7283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Vitamin D Deficiency, Premature infant, Vitamin D