NCT01469650

Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 23 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

Summary

This study will determine levels of vitamin D supplementation to achieve goal serum 25-hydroxy vitamin D \[25(OH)D\] levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in Newborn Intensive Care Nursery (NICU). Infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day.

Detailed description

The specific aims of this study are to determine levels of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the Nebraska Medical Center Newborn Intensive Care Nursery (NICU). In this randomized, controlled trial, infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day. As an exploratory aim, vitamin D binding protein levels (VDBP) will also be quantified in these infants.

Conditions

• Premature Infants

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cholecalciferal	400 IU/day
DIETARY_SUPPLEMENT	cholecalciferol	800 IU/day D3

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-01-01
• Completion: 2013-07-01
• First posted: 2011-11-10
• Last updated: 2023-09-06

Locations

1 site across 1 country: United States