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

Primary Purpose

Premature Infants

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cholecalciferal
cholecalciferol
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Infants focused on measuring vitamin D3, prematurity, parathyroid hormone, 25(OH)D, NICU hospitalization

Eligibility Criteria

23 Weeks - 32 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • Unversity of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

400 IU/day vitamin D

800 IU/day vitamin D3

Arm Description

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

Subjects will receive 800 IU/day vitamin D3

Outcomes

Primary Outcome Measures

Serum 25-hydroxy vitamin D [25(OH)D] Levels
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

Parathyroid Hormone Levels
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.

Full Information

First Posted
November 8, 2011
Last Updated
September 1, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT01469650
Brief Title
Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
Official Title
Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infants
Keywords
vitamin D3, prematurity, parathyroid hormone, 25(OH)D, NICU hospitalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400 IU/day vitamin D
Arm Type
Active Comparator
Arm Description
Subjects will receive 400 IU/day of vitamin D3, as per current unit policy
Arm Title
800 IU/day vitamin D3
Arm Type
Experimental
Arm Description
Subjects will receive 800 IU/day vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferal
Other Intervention Name(s)
vitamin D3
Intervention Description
400 IU/day
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
vitamin D3
Intervention Description
800 IU/day D3
Primary Outcome Measure Information:
Title
Serum 25-hydroxy vitamin D [25(OH)D] Levels
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Parathyroid Hormone Levels
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corrine K Hanson, PhD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33305842
Citation
Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Results Reference
derived

Learn more about this trial

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

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