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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Infection
• Intervention / Treatment: Drug: High Dose Vitamin D; Dietary supplement: Usual Care; Drug: Standard Dose Vitamin D; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Death		12 months
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
Number of Urinary Tract Infections		12 months
Number of Other Infections		12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Aging (NIA); The American Geriatrics Society

Publications and helpful links

General Publications

• Ginde AA, Blatchford P, Breese K, Zarrabi L, Linnebur SA, Wallace JI, Schwartz RS. High-Dose Monthly Vitamin D for Prevention of Acute Respiratory Infection in Older Long-Term Care Residents: A Randomized Clinical Trial. J Am Geriatr Soc. 2017 Mar;65(3):496-503. doi: 10.1111/jgs.14679. Epub 2016 Nov 16.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: April 11, 2010
• First Submitted That Met QC Criteria: April 12, 2010
• First Posted (Estimate): April 13, 2010

Study Record Updates

• Last Update Posted (Actual): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Prevention; Immunosenescence; Geriatrics; Vitamin D Deficiency; Respiratory Infection; Nursing Home Residents
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 09-0899; K23AG040708 (U.S. NIH Grant/Contract); IND 106541 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No