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Vitamin D Status and Dose Response in Infants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042561
First Posted: January 5, 2010
Last Update Posted: November 9, 2011
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.
Collaborator:
Creighton University Medical Center
Information provided by (Responsible Party):
Corrine K. Hanson, University of Nebraska
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Vitamin D Status and Dose Response in Infants

Resource links provided by NLM:


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

Primary Outcome Measures:
  • serum 25(OH)D levels [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • serum C-reactive protein (CRP) [ Time Frame: 30 days ]
  • serum intact parathyroid hormone (iPTH) [ Time Frame: 30 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Corrine K. Hanson, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01042561     History of Changes
Other Study ID Numbers: 281-09
First Submitted: December 31, 2009
First Posted: January 5, 2010
Last Update Posted: November 9, 2011
Last Verified: November 2011

Keywords provided by Corrine K. Hanson, University of Nebraska:
vitamin d
prematurity
25(OH)D
infant
CRP
PTH

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