Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-29 @ 4:15 AM
Study NCT ID:
NCT01469650
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2011-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
Sponsor:
University of Nebraska
Organization:
Study Overview
Official Title:
Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: