Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2009-08-07
2010-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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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.
vitamin D3 placebo
Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
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.
Vitamin D3
400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
Interventions
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Vitamin D3
400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
vitamin D3 placebo
Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* exclusively formula fed.
Exclusion Criteria
* 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.
5 Minutes
3 Months
ALL
Yes
Sponsors
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Creighton University Medical Center
OTHER
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Corrine Hanson, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
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References
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Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Other Identifiers
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0281-09-FB
Identifier Type: -
Identifier Source: org_study_id
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