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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Infection

Intervention / Treatment
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* Drug: High Dose Vitamin D
* Drug: Standard Dose Vitamin D
* Drug: Placebo
* Dietary Supplement: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60+ years Resides in nursing home 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose Vitamin D<br>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. | Drug: High Dose Vitamin D<br>* Vitamin D3 100,000 IU monthly<br>Dietary Supplement: Usual Care<br>* Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.<br>|
| Active Comparator: Standard Dose Vitamin D<br>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. | Drug: Standard Dose Vitamin D<br>* Vitamin D 12,000 IU monthly<br>Drug: Placebo<br>* Placebo monthly<br>Dietary Supplement: Usual Care<br>* Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Acute Respiratory Infections (ARIs) | ARIs defined as upper or lower respiratory infections | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Acute Respiratory Infections | ARIs resulting in emergency department visits or hospitalizations | 12 month | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D Deficiency, Respiratory Infection, Nursing Home Residents, Geriatrics, Immunosenescence, Prevention