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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05615311
Collaborator
(none)
126
Enrollment
1
Location
2
Arms
17.1
Anticipated Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamin D supplementation
  • Other: No additional vitamin D supplementation
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Racial Differences in Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: a Randomized Trial
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Vitamin D group

Dietary Supplement: Vitamin D supplementation
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.
Placebo Comparator: Control group

Other: No additional vitamin D supplementation
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.

Outcome Measures

Primary Outcome Measures

  1. Severity of respiratory morbidity [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 [40 - 120 days]

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

Secondary Outcome Measures

  1. Bronchopulmonary dysplasia [36 weeks PMA or discharge]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 4 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35233

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ariel A. Salas, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05615311
Other Study ID Numbers:
  • IRB-300010307
First Posted:
Nov 14, 2022
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Premature Birth
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins

Study Results

No Results Posted as of Jan 25, 2023