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

This study is not yet open for participant recruitment.
Verified November 2011 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Corrine K. Hanson, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01469650
First received: November 8, 2011
Last updated: November 9, 2011
Last verified: November 2011
History of Changes

November 8, 2011
November 9, 2011
January 2012
January 2013   (final data collection date for primary outcome measure)
Serum 25(OH)D Levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01469650 on ClinicalTrials.gov Archive Site
Parathyroid Hormone Levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Serum 25(OH)D Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
Serum 25(OH)D Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Premature Infants
  • Dietary Supplement: cholecalciferal
    400 IU/day
    Other Name: vitamin D3
  • Dietary Supplement: cholecalciferol
    800 IU/day D3
    Other Name: vitamin D3
  • Active Comparator: 400 IU/day vitamin D
    Subjects will receive 400 IU/day of vitamin D3, as per current unit policy
    Intervention: Dietary Supplement: cholecalciferal
  • Experimental: 800 IU/day vitamin D3
    Subjects will receive 800 IU/day vitamin D3
    Intervention: Dietary Supplement: cholecalciferol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
July 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
23 Weeks to 32 Weeks
No
Contact: Corrine K Hanson, PhD 402-559-3658 ckhanson@unmc.edu
United States
 
NCT01469650
419-11
No
Corrine K. Hanson, University of Nebraska
University of Nebraska
Not Provided
Not Provided
University of Nebraska
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP