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Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight

Recruiting
24 - 96 years of age
Both
Phase N/A

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Overview

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 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.

Study details

Vitamin D Deficiency

NCT05694689

The University of Texas Health Science Center, Houston

14 May 2024

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