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

Purpose

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

  • Prematurity; Extreme

Eligibility

Eligible Ages
Between 1 Day and 4 Days
Eligible Genders
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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Ariel A. Salas, MD, MSPH

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Ariel A. Salas, MD, MSPH
205-934-4680
asalas@uab.edu