NCT01102374

Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Respiratory Infection

Interventions

Type	Name	Description
DRUG	High Dose Vitamin D	Vitamin D3 100,000 IU monthly
DRUG	Standard Dose Vitamin D	Vitamin D 12,000 IU monthly
DRUG	Placebo	Placebo monthly
DIETARY_SUPPLEMENT	Usual Care	Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-08-01
• Completion: 2016-07-01
• First posted: 2010-04-13
• Last updated: 2017-04-21
• Results posted: 2017-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study