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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Nebraska.
Recruitment status was  Not yet recruiting
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
  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: Double Blind (Subject, Caregiver, 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 University of Nebraska:

Primary Outcome Measures:
  • Serum 25(OH)D Levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parathyroid Hormone Levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated 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

Ages Eligible for Study:   23 Weeks to 32 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469650

Contacts
Contact: Corrine K Hanson, PhD 402-559-3658 ckhanson@unmc.edu

Locations
United States, Nebraska
Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Corrine K Hanson, PhD    402-559-3658    ckhanson@unmc.edu   
Principal Investigator: Corrine Hanson, Phd         
Principal Investigator: Ann Anderson Berry, MD         
Principal Investigator: Laura Armas, MD         
Sponsors and Collaborators
University of Nebraska
  More Information

No publications provided

Responsible Party: Corrine K. Hanson, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01469650     History of Changes
Other Study ID Numbers: 419-11
Study First Received: November 8, 2011
Last Updated: November 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
vitamin D3
prematurity
parathyroid hormone
25(OH)D
NICU hospitalization

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Hormones
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014