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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01469650
First Posted: November 10, 2011
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Corrine K. Hanson, PhD, University of Nebraska
  Purpose
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 Intervention
Premature Infants Dietary Supplement: cholecalciferal Dietary Supplement: cholecalciferol

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Corrine K. Hanson, PhD, University of Nebraska:

Primary Outcome Measures:
  • Serum 25(OH)D Levels [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Parathyroid Hormone Levels [ Time Frame: 1 year ]

Enrollment: 32
Actual Study Start Date: January 2012
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: vitamin D3
Experimental: 800 IU/day vitamin D3
Subjects will receive 800 IU/day vitamin D3
Dietary Supplement: cholecalciferol
800 IU/day D3
Other Name: vitamin D3

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469650


Locations
United States, Nebraska
Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
  More Information

Responsible Party: Corrine K. Hanson, PhD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01469650     History of Changes
Other Study ID Numbers: 419-11-FB
First Submitted: November 8, 2011
First Posted: November 10, 2011
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Corrine K. Hanson, PhD, University of Nebraska:
vitamin D3
prematurity
parathyroid hormone
25(OH)D
NICU hospitalization

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Hormones
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hormones, Hormone Substitutes, and Hormone Antagonists