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Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT05694689•The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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).

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The University of Texas Medical Branch

Galveston, Texas, United States

Key Dates

Start Date

February 15, 2023

Primary Completion Date

January 1, 2026

Completion Date

June 1, 2029

Last Updated

September 29, 2025

Enrollment

ESTIMATED participants

Conditions

Vitamin D Deficiency

Interventions

Placebo

DIETARY_SUPPLEMENT

800 IU/day vitamin D supplementation with feedings in the first 28 days after birth

DIETARY_SUPPLEMENT

Usual Care

OTHER

Contacts

Sunil Jain, MD

CONTACT

409-772-2815 skjain@utmb.edu

Jordan Burdine, PharmD, MBA, BCPPS

CONTACT

409-772-5070 jlburdin@utmb.edu

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

NCT03188796

Critical IllnessVitamin D Deficiency+1 more

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Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

NCT06450925

Graft Vs Host DiseaseVitamin A Deficiency+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.

Isolation of Vitamin D Binding Protein Isoforms From Human Volunteers

Cholecalciferol in Newly Diagnosed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia With Vitamin D Deficiency

Peripheral Immunological Effects of High-dose Vitamin D Treatment in Healthy Subjects

Daily Vitamin D for Sickle-cell Respiratory Complications