NCT01600430

Vitamin D Supplementation for Extremely Preterm Infants

Early Vitamin D Supplementation for Prevention of Respiratory Morbidity in Extremely Preterm Infants: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Minute – 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin D Deficiency
• Preterm Infants
• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol	200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours. Other 3 doses will be placebo (sterile water). Duration of 28 postnatal days
DIETARY_SUPPLEMENT	Cholecalciferol	800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours. Duration of 28 postnatal days
DIETARY_SUPPLEMENT	Placebo	Sterile water 0.5ml given orally every 6 hours. Duration of 28 postnatal days

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-12-01
• Completion: 2016-12-01
• First posted: 2012-05-17
• Last updated: 2017-02-10

Locations

1 site across 1 country: United States