ViDES Trial (Vitamin D Extra Supplementation)

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER, HOUSTON · Jul 11, 2022

Keywords

ClinConnect Summary

The ViDES Trial is a research study looking at the effects of vitamin D supplementation in extremely premature infants, specifically those born before 28 weeks of pregnancy or weighing less than 1000 grams at birth. The study aims to find out if giving these infants an extra 800 IU of vitamin D each day for the first 28 days after birth can improve their vitamin D levels and possibly benefit their lung, bone, immune system, and brain health.

To participate in this trial, infants must be born early (less than 28 weeks) or have a low birth weight (under 1000 grams) and must be enrolled with the permission of their parents. Unfortunately, infants who are older than 32 weeks, have major birth defects, or certain health conditions will not be eligible. Families involved in the study can expect close monitoring of their baby’s health and development as researchers gather important information about the potential benefits of vitamin D in these vulnerable infants.

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
• • A 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.