Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight
The University of Texas Health Science Center, Houston
50 participants
Feb 15, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria5
- 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.
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Interventions
Placebo is normal saline, given in the first 28 days after birth, prepared to have the same volume and appearance as vitamin D, which is a clear odorless solution.
800 IU/day Vitamin D supplementation until 400 IU/ day are provided as part of usual care. At that point the intervention becomes a supplement of 400 IU/day above that given with usual care. In this way all infants in the intervention group receive 800 IU/day of vitamin D total supplementation in the first 28 days after birth with feedings.
Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05694689