NCT05459298

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Sep 2022Dec 2027

First Submitted

Initial submission to the registry

July 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2025

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

2.9 years

First QC Date

July 11, 2022

Last Update Submit

September 25, 2025

Conditions

Vitamin D Deficiency

Keywords

Premature infantVitamin D

Outcome Measures

Primary Outcomes (1)

  • 25-hydroxyvitamin D (25[OH]D) level

    about 28 days after birth

Secondary Outcomes (36)

  • 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)

  • +31 more secondary outcomes

Study Arms (2)

Usual care plus placebo

ACTIVE COMPARATOR

Infants will receive placebo (normal saline) in the first 28 days after birth. Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.

Dietary Supplement: PlaceboOther: 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 (when feedings reach about 120 -160 mL/kg/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 birthOther: Usual Care

Interventions

PlaceboDIETARY_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 birthDIETARY_SUPPLEMENT

800 IU/day Vitamin D supplementation until 400 IU/day are provided as part of usual care (started when infants receive full feedings of about 120-160 mL/kg/day). 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 CareOTHER

Care will be unaffected and provided based on the judgment of the attending neonatal faculty and NICU policies and routine practices. When the infant receives about 120 to 160 mL/kg/day of fortified milk at 24 kcal/ounce, the infant will receive supplementation with 400 IU/day of vitamin D as usual care.

Usual care plus placeboUsual care plus vitamin D supplementation

Eligibility Criteria

Age24 Hours - 96 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (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
  • A 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77006, United States

Location

Related Publications (2)

  • Romero-Lopez M, Tyson JE, Naik M, Pedroza C, Holzapfel LF, Avritscher E, Mosquera R, Khan A, Rysavy M. Randomized Controlled Trial of Enteral Vitamin D Supplementation (ViDES) in Infants <28 Weeks Gestational Age or <1000 Grams Birth Weight: Study Protocol. Res Sq [Preprint]. 2024 Jun 25:rs.3.rs-4049246. doi: 10.21203/rs.3.rs-4049246/v1.

    PMID: 38978597DERIVED

  • Romero-Lopez M, Tyson JE, Naik M, Pedroza C, Holzapfel LF, Avritscher E, Mosquera R, Khan A, Rysavy M. Randomized controlled trial of enteral vitamin D supplementation (ViDES) in infants <28 weeks gestational age or <1000 g birth weight: study protocol. Trials. 2024 Jun 28;25(1):423. doi: 10.1186/s13063-024-08274-8.

    PMID: 38943179DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyPremature Birth

Interventions

Saline SolutionCholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Maria del Mar Romero López, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

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

July 11, 2022

First Posted

July 14, 2022

Study Start

September 6, 2022

Primary Completion

August 12, 2025

Study Completion (Estimated)

December 1, 2027

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)