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

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT01469650

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Infants	Dietary Supplement: cholecalciferal Dietary Supplement: cholecalciferol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 400 IU/day vitamin D Subjects will receive 400 IU/day of vitamin D3, as per current unit policy	Dietary Supplement: cholecalciferal 400 IU/day Other Names: vitamin D3
Experimental: 800 IU/day vitamin D3 Subjects will receive 800 IU/day vitamin D3	Dietary Supplement: cholecalciferol 800 IU/day D3 Other Names: vitamin D3

Arm

Intervention/Treatment

Active Comparator: 400 IU/day vitamin D

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

Dietary Supplement: cholecalciferal

400 IU/day

Other Names:

vitamin D3

Experimental: 800 IU/day vitamin D3

Subjects will receive 800 IU/day vitamin D3

Dietary Supplement: cholecalciferol

800 IU/day D3

Other Names:

vitamin D3

Outcome Measures

Primary Outcome Measures

Serum 25(OH)D Levels [1 year]

Secondary Outcome Measures

Parathyroid Hormone Levels [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Weeks to 32 Weeks

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nebraska Medical Center	Omaha	Nebraska	United States	68198

Sponsors and Collaborators

University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Corrine K. Hanson, PhD, Assistant Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT01469650

Other Study ID Numbers:

419-11-FB

First Posted:

Nov 10, 2011

Last Update Posted:

Sep 14, 2017

Last Verified:

Sep 1, 2017

Keywords provided by Corrine K. Hanson, PhD, Assistant Professor, University of Nebraska

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2017