This study will test the role of high dose vitamin D supplementation in prevention of acute respiratory infection in older nursing home residents. The investigators hypothesize that residents on high dose vitamin D supplementation will have a lower incidence of acute respiratory infection that those on standard dose vitamin D supplementation.
This study is a double-blinded, parallel group, randomized controlled phase II trial of oral high vs. standard dose vitamin D3 supplementation administered monthly for 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
107
University of Colorado Denver
Aurora, Colorado, United States
Number of Acute Respiratory Infections (ARIs)
ARIs defined as upper or lower respiratory infections
Time frame: 12 months
Severity of Acute Respiratory Infections
ARIs resulting in emergency department visits or hospitalizations
Time frame: 12 month
Time to First ARI
Time frame: 12 months
Change in 25-hydroxyvitamin D (25OHD) Level
Time frame: Baseline and 12 months
Change in Parathyroid Hormone Level
Time frame: Baseline and 12 months
Falls
Time frame: 12 months
Fractures
Time frame: 12 months
Number of Upper Respiratory Infections
Time frame: 12 months
Number of Lower Respiratory Infections
Time frame: 12 months
Number of Influenza-like Illnesses
Time frame: 12 months
Incident Kidney Stones
Time frame: 12 months
Incident Hypercalcemia
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Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
Time frame: 12 months
Death
Time frame: 12 months
Number of Urinary Tract Infections
Time frame: 12 months
Number of Other Infections
Time frame: 12 months