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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 24 Hours and 96 Hours
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Usual care plus placebo 		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: Placebo
    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.
    Other names:
    • Normal saline
  • Other: Usual Care
    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.
Experimental
Usual care plus vitamin D supplementation 		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 birth
    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.
    Other names:
    • Cholecalciferol
  • Other: Usual Care
    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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77006
Contact:
Maria del Mar Romero López, MD
713-500-7283
Maria.del.Mar.RomeroLopez@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Maria del Mar Romero López, MD
713-500-7283
Maria.del.Mar.RomeroLopez@uth.tmc.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.