Actively Recruiting
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
Led by The University of Texas Health Science Center, Houston · Updated on 2025-09-29
50
Participants Needed
1
Research Sites
328 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).
CONDITIONS
Official Title
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born at less than 28 weeks gestational age or weighing less than 1000 grams
- Born in the hospital where the study is conducted (inborn)
- Informed written consent obtained in an Institutional Review Board-approved manner
You will not qualify if you...
- Gestational age greater than 32 weeks regardless of birth weight
- Major congenital anomalies
- Known congenital nonbacterial infections
- Prenatal diagnosis of disorders affecting vitamin D absorption (e.g., cystic fibrosis)
- Severe illness or immaturity judged by the neonatologist to make intensive care unjustified
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas Medical Branch
Galveston, Texas, United States, 77555
Actively Recruiting
Research Team
S
Sunil Jain, MD
CONTACT
J
Jordan Burdine, PharmD, MBA, BCPPS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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