RecruitingNot Applicable

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

United States50 participantsStarted 2023-02-15

Plain-language 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).

Who can participate

Age range24 Hours – 96 Hours

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

25-hydroxyvitamin D (25[OH]D) level

Timeframe: about 28 days after birth

Trial details

NCT IDNCT05694689

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

Contact for this trial

Sunil Jain, MD

409-772-2815 skjain@utmb.edu

View on ClinicalTrials.gov More Vitamin D Deficiency trials