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

NCT ID: NCT01469650

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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.

Conditions

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Premature Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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400 IU/day vitamin D

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

Group Type ACTIVE_COMPARATOR

cholecalciferal

Intervention Type DIETARY_SUPPLEMENT

400 IU/day

800 IU/day vitamin D3

Subjects will receive 800 IU/day vitamin D3

Group Type EXPERIMENTAL

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

800 IU/day D3

Interventions

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cholecalciferal

400 IU/day

Intervention Type DIETARY_SUPPLEMENT

cholecalciferol

800 IU/day D3

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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vitamin D3 vitamin D3

Eligibility Criteria

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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
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corrine K Hanson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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Unversity of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33305842 (View on PubMed)

Other Identifiers

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0419-11-FB

Identifier Type: -

Identifier Source: org_study_id

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