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

NCT01469650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-09-06

No results posted yet for this study

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.

Conditions

  • Premature Infants

Interventions

DIETARY_SUPPLEMENT

cholecalciferal

400 IU/day

DIETARY_SUPPLEMENT

cholecalciferol

800 IU/day D3

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Corrine K Hanson, PhD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
23 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-01-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01469650 on ClinicalTrials.gov