RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-02-15
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05694689

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:24 Hours to 96 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Infants born at \< 28 weeks gestational age (GA) or \<1000 grams birth weight (BW)
  2. * Inborn
  3. * Informed written consent in an Institutional Review Board (IRB)-approved manner
  1. * GA \>32 weeks regardless of birth weight (BW)
  2. * Any major congenital anomaly
  3. * An known congenital nonbacterial infection
  4. * Prenatal diagnosis of disorders that affect vitamin D absorption (e.g, cystic fibrosis)
  5. * Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.

Contacts and Locations

Study Contact

Sunil Jain, MD
CONTACT
409-772-2815
skjain@utmb.edu
Jordan Burdine, PharmD, MBA, BCPPS
CONTACT
409-772-5070
jlburdin@utmb.edu

Principal Investigator

Sunil Jain, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Medical Branch

Study Locations (Sites)

The University of Texas Medical Branch
Galveston, Texas, 77555
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-15
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2023-02-15
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • Premature infant
  • Vitamin D

Additional Relevant MeSH Terms

  • Vitamin D Deficiency