Vitamin D Supplementation for Premature Infants

N/A

Recruiting

Led By Sunil Jain, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Summary

This trial will compare vitamin D supplementation to usual care in premature babies. Results will be used to measure effects on lung, bone, immune, and brain health.

Who is the study for?

This trial is for very premature infants born at less than 28 weeks or weighing under 1000 grams. It's not for babies with conditions affecting vitamin D absorption, like cystic fibrosis, those too sick where intensive care isn't justified, with congenital infections, over 32 weeks gestation, or with major birth defects.

What is being tested?

The study tests if giving a high dose of vitamin D (800 IU/day) to extremely premature babies helps their bones, lungs, immune system and brain compared to usual care. Babies are randomly given either the vitamin D supplement or no extra vitamins in their first month.

What are the potential side effects?

Since this trial involves administering vitamin D to preterm infants, potential side effects may include signs of too much calcium like irritability or vomiting but specific risks will be closely monitored by healthcare professionals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Head circumference as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

Length as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator

Neurodevelopment as assessed by the Bayley-IV Scale of Infant and Toddler Development (Cognitive composite score)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Usual care plus vitamin D supplementationExperimental Treatment2 Interventions

Infants will receive cholecalciferol 800 IU/day in the first 28 days after birth, given enterally four times per day (0.5mL per dose = 200 IU) until the infant is provided 400 IU/day. At that point the study cholecalciferol will be reduced to 400 IU/day for a total supplementation of 800 IU/day.

Group II: Usual care plus placeboActive Control2 Interventions

Infants will receive placebo (normal saline) in the first 28 days after birth. Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices.

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