search
Back to results

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

Primary Purpose

Respiratory Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High Dose Vitamin D
Standard Dose Vitamin D
Placebo
Usual Care
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Infection focused on measuring Vitamin D Deficiency, Respiratory Infection, Nursing Home Residents, Geriatrics, Immunosenescence, Prevention

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Dose Vitamin D

Standard Dose Vitamin D

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Acute Respiratory Infections (ARIs)
ARIs defined as upper or lower respiratory infections

Secondary Outcome Measures

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

Full Information

First Posted
April 11, 2010
Last Updated
April 18, 2017
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA), The American Geriatrics Society
search

1. Study Identification

Unique Protocol Identification Number
NCT01102374
Brief Title
Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Official Title
Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA), The American Geriatrics Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infection
Keywords
Vitamin D Deficiency, Respiratory Infection, Nursing Home Residents, Geriatrics, Immunosenescence, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose Vitamin D
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Dose Vitamin D
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
High Dose Vitamin D
Intervention Description
Vitamin D3 100,000 IU monthly
Intervention Type
Drug
Intervention Name(s)
Standard Dose Vitamin D
Intervention Description
Vitamin D 12,000 IU monthly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo monthly
Intervention Type
Dietary Supplement
Intervention Name(s)
Usual Care
Intervention Description
Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
Primary Outcome Measure Information:
Title
Number of Acute Respiratory Infections (ARIs)
Description
ARIs defined as upper or lower respiratory infections
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Severity of Acute Respiratory Infections
Description
ARIs resulting in emergency department visits or hospitalizations
Time Frame
12 month
Title
Time to First ARI
Time Frame
12 months
Title
Change in 25-hydroxyvitamin D (25OHD) Level
Time Frame
Baseline and 12 months
Title
Change in Parathyroid Hormone Level
Time Frame
Baseline and 12 months
Title
Falls
Time Frame
12 months
Title
Fractures
Time Frame
12 months
Title
Number of Upper Respiratory Infections
Time Frame
12 months
Title
Number of Lower Respiratory Infections
Time Frame
12 months
Title
Number of Influenza-like Illnesses
Time Frame
12 months
Title
Incident Kidney Stones
Time Frame
12 months
Title
Incident Hypercalcemia
Time Frame
12 months
Title
Death
Time Frame
12 months
Title
Number of Urinary Tract Infections
Time Frame
12 months
Title
Number of Other Infections
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adit A Ginde, MD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27861708
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs