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Trials / Completed

CompletedNCT01042561

Vitamin D Status and Dose Response in Infants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
University of Nebraska · Academic / Other
Sex
All
Age
5 Minutes – 3 Months
Healthy volunteers
Accepted

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.

Detailed description

It is hypothesized 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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTVitamin D3400 IU of vitamin D3 daily. Pts will recieve 1 mL a day with a feeding for 28 days.
DIETARY_SUPPLEMENTvitamin D3 placeboPlacebo designed by research pharmacist. Pts will recieve 1 mL a day with feedings for 28 days.

Timeline

Start date
2009-08-07
Primary completion
2010-08-01
Completion
2010-08-01
First posted
2010-01-05
Last updated
2023-09-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01042561. Inclusion in this directory is not an endorsement.

Vitamin D Status and Dose Response in Infants (NCT01042561) · Clinical Trials Directory