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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.