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

Phase 2

Completed

• Conditions: Respiratory Infection
• Interventions: Drug: High Dose Vitamin D; Drug: Standard Dose Vitamin D; Dietary Supplement: Usual Care; Drug: Placebo

• Registration Number: NCT01102374
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Study Timeline

• Study First Submitted: 2010-04-11
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Study Start: 2010-05
• Primary Completion: 2014-08
• Study Completion: 2016-07
• Results First Submitted: 2016-10-28
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-18
• Last Update Submitted: 2017-04-18
• Results First Posted: 2017-04-21
• Last Update Posted: 2017-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Age 60+ years
• Resides in nursing home

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Exclusion Criteria

• Terminal illness (expected survival <6 months)
• Anticipated discharge within 12 months
• Unable to take whole or crushed tablets
• Active cancer, except squamous/basal cell carcinoma
• Severe malnutrition (body mass index <18 kg/m2)
• Current immunosuppressive medications (including corticosteroids)
• Renal failure (estimated glomerular filtration rate < 15 mL/min/1.73m2)
• Currently taking >1,000 IU/d vitamin D supplementation
• History (or strong family history) of kidney stones
• History of sarcoidosis or other granulomatous disorders associated with hypercalcemia
• Elevated baseline hypercalcemia (albumin-adjusted serum calcium >10.5 mg/dL)
• Baseline serum 25OHD level ≥ 100 nmol/L
• Inability to provide informed consent and no available healthcare legally authorized representative
• Inability of participant or legally authorized representative to speak/understand English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Vitamin D	High Dose Vitamin D	100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
High Dose Vitamin D	Usual Care	100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.
Standard Dose Vitamin D	Standard Dose Vitamin D	12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D	Placebo	12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.
Standard Dose Vitamin D	Usual Care	12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.

Primary Outcome Measures

Name	Time	Method
Number of Acute Respiratory Infections (ARIs)	12 months	ARIs defined as upper or lower respiratory infections

Secondary Outcome Measures

Name	Time	Method
Severity of Acute Respiratory Infections	12 month	ARIs resulting in emergency department visits or hospitalizations
Time to First ARI	12 months
Change in 25-hydroxyvitamin D (25OHD) Level	Baseline and 12 months
Change in Parathyroid Hormone Level	Baseline and 12 months
Falls	12 months
Fractures	12 months
Number of Upper Respiratory Infections	12 months
Number of Lower Respiratory Infections	12 months
Number of Influenza-like Illnesses	12 months
Incident Kidney Stones	12 months
Incident Hypercalcemia	12 months
Death	12 months
Number of Urinary Tract Infections	12 months
Number of Other Infections	12 months

Trial Locations

Locations (1)

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States