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NCT Number: NCT05615311

Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm

This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during the first 14 days after birth.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prematurity; Extreme Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–4 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age of 28 weeks or less

Exclusion criteria

  • Major congenital anomalies and infants
  • Terminal illness in whom decisions to withhold or limit life support have been made

Treatment and study plan

Vitamin D Supplementation

Dietary Supplement

Study participants assigned to the intervention group will receive 800 IU/ day of vitamin D plus 200-300 IU/day of vitamin D from parenteral and enteral sources during the first 2 weeks after birth.

No additional vitamin D supplementation

Other

Study participants assigned to the control group will receive 200-300 IU/ day of vitamin D from parenteral and enteral sources during the first 2 weeks after birth.

Primary outcomes

  1. Severity of respiratory morbidity

    Time frame: 0 - 120 days

    A scoring system that defines severity of respiratory morbidity based on the amount of ventilatory support and the need for supplemental oxygen

  2. Non-invasive oscillometry (NiOS) measurements of pulmonary mechanics

    Time frame: 40 - 120 days

    Using the tremoflo N-100 Neo Oscillometry device, we will determine the area under the reactance curve (AX)

Secondary outcomes

  1. Bronchopulmonary dysplasia

    Time frame: 36 weeks PMA or discharge

    Number of participants receiving ventilatory support or supplemental oxygen at 36 weeks of postmenstrual age (PMA) or discharge

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: A Randomized Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Nov 14, 2022
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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