Vitamin D Status and Dose Response in Infants
1 other identifier
interventional
64
1 country
1
Brief Summary
This study will examine the relationship of serum 25(OH)D levels in infants 32 weeks and greater gestation who are fed infant formula to markers of inflammation and bone metabolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 7, 2009
CompletedFirst Submitted
Initial submission to the registry
December 31, 2009
CompletedFirst Posted
Study publicly available on registry
January 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedSeptember 1, 2023
August 1, 2023
12 months
December 31, 2009
August 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum 25-Hydroxyvitamin D [25(OH)D] Levels
Total serum 25(OH)D level is currently considered the best indicator of vitamin D supply to the body from cutaneous synthesis and nutritional intake. For infants, ≤37.5 nmol/L (15 ng/mL) would be considered indicative of deficiency and \>50 nmol/L (20 ng/mL) as indicative of vitamin D sufficiency.
30 days
Secondary Outcomes (2)
Serum C-reactive protein (CRP)
30 days
Serum intact parathyroid hormone (iPTH)
30 days
Study Arms (2)
placebo
PLACEBO COMPARATORThis 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 D
EXPERIMENTALThis 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.
Interventions
400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
Placebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.
Eligibility Criteria
You may qualify if:
- greater than 32 weeks gestation,
- exclusively formula fed.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nebraskalead
- Creighton University Medical Centercollaborator
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Related Publications (1)
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.
PMID: 33305842DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Corrine Hanson, PhD, RD
University of Nebraska
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2009
First Posted
January 5, 2010
Study Start
August 7, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
September 1, 2023
Record last verified: 2023-08