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 type | Interventional |
|---|---|
| Ages | 24 Hours to 96 Hours |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05459298 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
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Vitamin D Supplementation in Children with Irritable Bowel Syndrome
This study tests whether giving vitamin D to children with IBS and low vitamin D levels can improve their IBS symptoms compared with a placebo.
-
Vitamin D and dental implant osseointegration in adults with deficiency
This study tests whether giving vitamin D helps improve how well dental implants fuse with bone in adults who are deficient.
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Vitamin D2 with Calcitriol in kids with cholestasis and vitamin D deficiency
This study tests whether adding calcitriol to vitamin D2 helps children with cholestasis and vitamin D deficiency reach healthier vitamin D levels.
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Vitamin D and the body's anti-inflammatory response in gum disease
This study tests whether vitamin D can modulate the body's anti-inflammatory response in people with gum disease.
-
Bone Myoregulation and Posture in Vitamin D Deficiency
This observational study tests whether adults with vitamin D deficiency differ in postural stability and muscle activity from healthy controls during a single-session, noninvasive assessment.
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Adding exercise to vitamin D treatment for diabetic men with erectile dysfunction and low vitamin D.
This trial will see if adding regular moderate treadmill walking to high‑dose vitamin D replacement helps men with type 2 diabetes, chronic erectile dysfunction, and low vitamin D levels.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.