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

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Jan 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of vitamin D supplementation in very premature infants, specifically those born before 28 weeks of pregnancy or weighing less than 1000 grams at birth. The main goal is to see if giving these infants 800 IU of vitamin D each day for the first 28 days after birth can improve their vitamin D levels and potentially benefit their lung function, bone development, immune system, and brain health.

To participate in this study, infants must be born before 28 weeks of gestation or weigh less than 1000 grams. They should be in good enough condition to receive this supplementation, and parents will need to provide informed consent for their participation. The study is currently recruiting participants, and all infants will be monitored to see how well they respond to the vitamin D, compared to those who receive standard care. This trial is important because it could help improve the health outcomes of extremely premature infants who are at risk for vitamin D deficiency.

Gender

ALL

Eligibility criteria

• 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.