Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight

The University of Texas Health Science Center, Houston50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Vitamin D Deficiency

Interventions

Placebo

800 IU/day vitamin D supplementation with feedings in the first 28 days after birthDIETARY_SUPPLEMENT

800 IU/day Vitamin D supplementation until 400 IU/ day are provided as part of usual care. 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.

Eligibility

Sex: ALLMin age: 24 HoursMax age: 96 Hours

Medical Language ↔ Plain English

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 * An 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.

Outcomes

Primary Outcomes

25-hydroxyvitamin D (25[OH]D) level

Time frame: about 28 days after birth

Secondary Outcomes

25-hydroxyvitamin D (25[OH]D) level

Time frame: 36 weeks after birth

Type of respiratory support required at 36 weeks postmenstrual age

Data will be reported categorically as: * Number of participants who survive without respiratory support * Number of participants who survive with nasal cannula at ≤ 2 liters (L)/minute * Number of participants who survive with nasal cannula \>2 L/minute or noninvasive positive airway pressure * Number of participants who survive with invasive mechanical ventilation * Number of participants who die

Time frame: 36 weeks postmenstrual age (or at the time of discharge home if earlier)

Length of Hospital stay

Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)

Number of participants who are still on respiratory support

Respiratory support includes supplemental oxygen and positive pressure ventilation.

Time frame: 22 to 26 months corrected age

Number of days of supplemental oxygen

Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)

Number of days of mechanical ventilation

Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)

Number of days of positive pressure support

Time frame: from time of birth to time of discharge (about 0 to 60 weeks after birth)

Number of participants who receive steroid treatment to decrease respiratory support

Time frame: from baseline to 36 weeks postmenstrual age

Number of participants with pulmonary hypertension

Time frame: 36 weeks postmenstrual age

Number of participants with wheezing

Time frame: 2 years

Weight as assessed by sex-specific Z-score on the Fenton 2013 Growth Calculator