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

University of Nebraska

Status: Completed

Conditions: Premature Infants

Treatments: Dietary Supplement: cholecalciferol; Dietary Supplement: cholecalciferal

Study type: Interventional

Funder types: Other

Identifiers

NCT01469650

0419-11-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 23 to 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups

400 IU/day vitamin D

Active Comparator group

Description:

Subjects will receive 400 IU/day of vitamin D3, as per current unit policy

Treatment:

Dietary Supplement: cholecalciferal

800 IU/day vitamin D3

Experimental group

Description:

Subjects will receive 800 IU/day vitamin D3

Treatment:

Dietary Supplement: cholecalciferol