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

NCT05694689 | Recruiting

• 1 other identifier: IRB # 22-0217
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Vitamin D Deficiency

Keywords

Premature infant; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 25-hydroxyvitamin D (25[OH]D) level

  about 28 days after birth

Secondary Outcomes (35)

• 25-hydroxyvitamin D (25[OH]D) level

  36 weeks after birth

• Type of respiratory support required at 36 weeks postmenstrual age

  36 weeks postmenstrual age (or at the time of discharge home if earlier)

• Length of Hospital stay

  from time of birth to time of discharge (about 0 to 60 weeks after birth)

• Number of participants who are still on respiratory support

  22 to 26 months corrected age

• Number of days of supplemental oxygen

  from time of birth to time of discharge (about 0 to 60 weeks after birth)

Study Arms (2)

Usual care plus placebo

ACTIVE COMPARATOR

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.

Dietary Supplement: Placebo; Other: Usual Care

Usual care plus vitamin D supplementation

EXPERIMENTAL

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.

Dietary Supplement: 800 IU/day vitamin D supplementation with feedings in the first 28 days after birth; Other: Usual Care

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo is normal saline, given in the first 28 days after birth, prepared to have the same volume and appearance as vitamin D, which is a clear odorless solution.

Also known as: Normal saline

Usual care plus placebo

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

800 IU/day Vitamin D supplementation until 400 IU/ day are provided as part of usual care. At that point the intervention becomes a supplement of 400 IU/day above that given with usual care. In this way all infants in the intervention group receive 800 IU/day of vitamin D total supplementation in the first 28 days after birth with feedings.

Also known as: Cholecalciferol

Usual care plus vitamin D supplementation

Usual Care OTHER

Co-interventions will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices

Usual care plus placebo; Usual care plus vitamin D supplementation

Eligibility Criteria

• Age: 24 Hours - 96 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency; Premature Birth

Interventions

Saline Solution; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sunil Jain, MD

  The University of Texas Medical Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunil Jain, MD

CONTACT

409-772-2815; skjain@utmb.edu

Jordan Burdine, PharmD, MBA, BCPPS

CONTACT

409-772-5070; jlburdin@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: February 15, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)