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Vitamin D Status and Dose Response in Infants

This study has been completed.
Sponsor:
Collaborator:
Creighton University Medical Center
Information provided by (Responsible Party):
Corrine K. Hanson, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01042561
First received: December 31, 2009
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

We hypothisize that serum 25(OH)D levels in infants 32 weeks and greater gestation are not maintained at optimal levels of greater than 32 ng/Ml with currently available infant formulas, and that this will have an inverse relationship with markers of inflammation and bone metabolism.


Condition Intervention Phase
Vitamin D
Prematurity
 Dietary Supplement: Vitamin D3
Dietary Supplement: vitamin D3 placebo
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Vitamin D Status and Dose Response in Infants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • serum 25(OH)D levels [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum C-reactive protein (CRP) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • serum intact parathyroid hormone (iPTH) [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
This group will recieve the current standard of care for infants in the NICU, recieving infant formula that provides less than 400 IU of vitamin D a day.
 Dietary Supplement: vitamin D3 placebo
Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
Experimental: Vitamin d
This group will recieve standard of care infant formulas that provide less than 400 IU of vitamin D a day, in addition they will be supplemented with 400 IU of vitamin D3 daily.
 Dietary Supplement: Vitamin D3
400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
Other Name: DVi-Sol

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • greater than 32 weeks gestation,
  • exclusively formula fed.

Exclusion Criteria:

  • less than 32 weeks gestation,
  • less than 1500 grams,
  • recieving maternal breast milk,
  • recieving parenteral nutrition,
  • congenital anomolies,
  • disorders of vitamin D metabolism,
  • inborn errors of metabolism,
  • seizure disorders,
  • parathroid disease,
  • liver, GI tract, or kidney disease, and
  • disorders of calcium metabolism.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042561

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

No publications provided

Responsible Party: Corrine K. Hanson, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01042561     History of Changes
Other Study ID Numbers: 281-09
Study First Received: December 31, 2009
Last Updated: November 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
vitamin d
prematurity
25(OH)D
 infant
CRP
PTH

Additional relevant MeSH terms:
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 21, 2013