Clinical trial NCT01600430: Vitamin D Supplementation for Extremely Preterm Infants
Official title: Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Vitamin D Deficiency
Preterm Infants
Bronchopulmonary Dysplasia
Keywords: Vitamin D
Newborn
Preterm
Supplementation
Respiratory
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Children's Health System, Alabama
First posted: 2012-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study hypothesis states that giving early enteral Vitamin D supplementation to preterm infants will decrease respiratory morbidity in extremely preterm infants.

Detailed description: After informed consent obtained, infants will be randomized using computer-generated stratified randomization codes by the pharmacy. Clinicians, researcher, and primary caregivers will be masked. Subjects will be randomly assigned to one of the treatment arms or to a placebo concurrent control.

Early vitamin D supplementation/placebo will be initiated within the first 7 days after birth. Premature infants will be randomized to receive one of the 3 fixed doses of vitamin D: either placebo (zero dose), 200 IU/day, or 800 IU/day. The supplementation will be started within 72 hours of enteral feeds being initiated and will continue until postnatal day 28. After this period of supplementation, routine supplementation will be conducted in all groups.

Remnant cord blood samples will be analyzed for vitamin D levels (serum hydroxyvitamin D \[25(OH)D\]. Two circulating vitamin D concentrations (25(OH)D concentrations) will be measured on postnatal days 14 and 28. Urine samples will be collected weekly, to determine calcium excretion if high serum calcium concentrations are found.

Supplementation will be discontinued and infant will exit the study if surgical necrotizing enterocolitis/bowel perforation is diagnosed, if 25 (OH)D concentrations \>60ng/mL (\>150nmol/L; potentially toxic) are detected or, if infant NPO for greater than 24 hours. If infant made briefly NPO (\<24h) for feeding intolerance, suspected sepsis, hypotension,hemodynamically significant PDA, or respiratory difficulties, enteral vitamin D will not be discontinued.

All infants will be followed to discharge for primary, secondary outcomes as well as adverse events.

Eligibility criteria: Inclusion Criteria:

* Infants admitted to the Regional Newborn ICU of the University of Alabama with gestational age between 23-27 completed weeks

Exclusion Criteria:

* Major congenital/chromosomal anomalies
* Moribund infant with low likelihood of survival, in opinion of the clinical team

Primary outcomes:
measure: Total number of days alive and off respiratory support in the first 28 days
timeFrame: 28 days
measure: Serum vitamin D concentration
timeFrame: Day after birth 28
Secondary outcomes:
measure: Number of sepsis episodes treated with antibiotics for at least 5 days
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 months
measure: Sepsis
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 months
measure: Need for supplemental oxygen at 36 weeks of corrected age (Physiologic definition)
timeFrame: 36 weeks gestational age corrected
measure: Duration of mechanical ventilation after randomization
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 months
measure: Days alive and off mechanical ventilation in the first 28 days after birth
timeFrame: 28 days
measure: Number of re-intubation events
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 months
measure: Death
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 months
measure: Surgical necrotizing enterocolitis or intestinal perforation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 months
measure: 25(OH)D concentrations >60ng/ml (150 nmol/L)
timeFrame: 14 postnatal (+/- 2 days)
measure: 25(OH)D concentrations >60ng/ml (150 nmol/L)
timeFrame: 28 days postnatal age (+/- 3 days)
measure: Serum calcium level
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 months
measure: Urine calcium level
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 months
measure: Meningitis
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 months
Other outcomes:
measure: Death or Neurodevelopmental Impairment
timeFrame: Birth to 22-26 months of age
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Namasivayam Ambalavanan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Ariel A. Salas, MD
role: STUDY_DIRECTOR
References:
citation: Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
citation: Fort P, Salas AA, Nicola T, Craig CM, Carlo WA, Ambalavanan N. A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial. J Pediatr. 2016 Jul;174:132-138.e1. doi: 10.1016/j.jpeds.2016.03.028. Epub 2016 Apr 11.