Vitamin D supplementation for premature infants
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
This study is testing if giving 800 IU of vitamin D each day can help extremely premature infants grow healthier by looking at their vitamin D levels and how it affects their lungs, bones, immune system, and brain during their first month of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 24 Hours to 96 Hours |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Galveston, Texas) |
| Trial ID | NCT05694689 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 infants born before 28 weeks of gestational age or weighing less than 1000 grams. The focus is on measuring vitamin D levels and assessing potential impacts on lung, bone, immune system, and brain function in extremely premature infants during their first 28 days of life. The analysis will utilize both intention-to-treat Bayesian methods and Frequentist approaches to evaluate the outcomes.
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 after 32 weeks of gestation or have major congenital anomalies or severe illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve health outcomes for extremely premature infants by addressing vitamin D deficiency and its associated complications.
How similar studies have performed: Other studies have shown promising results with vitamin D supplementation in premature infants, indicating potential benefits, although this specific approach may still be novel.
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 * An 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
Galveston, Texas
- The University of Texas Medical Branch — Galveston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sunil Jain, MD — The University of Texas Medical Branch
- Study coordinator: Sunil Jain, MD
- Email: skjain@utmb.edu
- Phone: 409-772-2815
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.