Back to search results

Vitamin D Supplementation for Premature Infants

This study is looking at whether giving extra vitamin D to very premature babies can improve their health. We are testing two approaches: giving 800 IU/day of vitamin D supplementation or giving a placebo (a substance with no active medicine, like normal saline) for the first 28 days after birth. This study is for infants born before 28 weeks of pregnancy or weighing less than 1000 grams, who are between 24 and 96 hours old. We want to see how these approaches affect their vitamin D levels and potentially their lungs, bones, immune system, and brain. The study aims to enroll 60 infants, but the current recruitment status is unclear.

Study design
This is an interventional study comparing vitamin D supplementation to a placebo or usual care, with a planned enrollment of 60 participants.
What's involved
Participants would receive either vitamin D supplementation or a placebo daily for the first 28 days after birth. Their 25-hydroxyvitamin D levels will be measured around 28 days after birth, and their respiratory support will be assessed at 36 weeks postmenstrual age or at discharge.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed until 36 weeks postmenstrual age or until they are discharged home, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05694689

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

Active, Not Recruiting
NAAges 24–96Interventional
The University of Texas Health Science Center, Houston
~60 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Placebo800 IU/day vitamin D supplementation with feedings in the first 28 days after birthUsual Care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
25-hydroxyvitamin D (25[OH]D) level
Measured over about 28 days after birth
+1 more outcome measured

Conditions

Vitamin D Deficiency

Explore related trials

Premature infantVitamin D Deficiency

NCT05694689

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Texas Medical Branch

    Galveston, Texasno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sunil Jain, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Medical Branch

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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 this trial measures

  • 25-hydroxyvitamin D (25[OH]D) levelabout 28 days after birth
  • Type of respiratory support required at 36 weeks postmenstrual age36 weeks postmenstrual age (or at the time of discharge home if earlier)

    Data will be reported categorically as: * Number of participants who survive without respiratory support * Number of participants who survive with nasal cannula at ≤ 2 liters (L)/minute * Number of participants who survive with nasal cannula \>2 L/minute or noninvasive positive airway pressure * Number of participants who survive with invasive mechanical ventilation * Number of participants who die