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

Not Applicable

Completed

• Conditions: Premature Infants
• Interventions: Dietary Supplement: cholecalciferol; Dietary Supplement: cholecalciferal

• Registration Number: NCT01469650
• Lead Sponsor: University of Nebraska

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 Timeline

• Study First Submitted: 2011-11-08
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-10
• Study Start: 2012-01
• Primary Completion: 2013-01
• Study Completion: 2013-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• NICU hospitalized infants
• 23-32 weeks gestation

Exclusion Criteria

• congential anomalies
• disorders of calcium metabolism
• inborn error of metabolism
• kidney disease
• liver disease
• use of steroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
800 IU/day vitamin D3	cholecalciferol	Subjects will receive 800 IU/day vitamin D3
400 IU/day vitamin D	cholecalciferal	Subjects will receive 400 IU/day of vitamin D3, as per current unit policy

Primary Outcome Measures

Name	Time	Method
Serum 25-hydroxy vitamin D [25(OH)D] Levels	1 year	Serum 25-hydroxy vitamin D \[25(OH)D\] levels will be compared between the two groups, vitamin D supplementation of 400 IU vitamin D3/day, or 800 IU vitamin D3/day. The specific aims of this study are to determine leves of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL.

Secondary Outcome Measures

Name	Time	Method
Parathyroid Hormone Levels	1 year	Parathyroid hormone levels will be compared in between the two groups, vitamin D supplementation of 400 IU vitamin D3/day, or 800 IU vitamin D3/day.

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States