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NCT05694689
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
Conditions: Vitamin D Deficiency
Sex: All
Ages: 24 Hours – 96 Hours
Phase: NA
Enrollment: 50
Sponsor: The University of Texas Health Science Center, Houston
Location: United States
Summary
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).
Eligibility Criteria
Inclusion Criteria:Infants born at < 28 weeks gestational age (GA) or <1000 grams birth weight (BW)InbornInformed written consent in an Institutional Review Board (IRB)-approved mannerExclusion Criteria:GA >32 weeks regardless of birth weight (BW)Any major congenital anomalyAn overt congenital nonbacterial infectionPrenatal 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.
Source: ClinicalTrials.gov (NCT05694689). StuddyBuddy aggregates publicly available trial information.