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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01102374
First Posted: April 13, 2010
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Aging (NIA)
The American Geriatrics Society
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose
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.

Condition Intervention Phase
Respiratory Infection Drug: High Dose Vitamin D Drug: Standard Dose Vitamin D Drug: Placebo Dietary Supplement: Usual Care Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Number of Acute Respiratory Infections (ARIs) [ Time Frame: 12 months ]
    ARIs defined as upper or lower respiratory infections


Secondary Outcome Measures:
  • Severity of Acute Respiratory Infections [ Time Frame: 12 month ]
    ARIs resulting in emergency department visits or hospitalizations

  • Time to First ARI [ Time Frame: 12 months ]
  • Change in 25-hydroxyvitamin D (25OHD) Level [ Time Frame: Baseline and 12 months ]
  • Change in Parathyroid Hormone Level [ Time Frame: Baseline and 12 months ]
  • Falls [ Time Frame: 12 months ]
  • Fractures [ Time Frame: 12 months ]
  • Number of Upper Respiratory Infections [ Time Frame: 12 months ]
  • Number of Lower Respiratory Infections [ Time Frame: 12 months ]
  • Number of Influenza-like Illnesses [ Time Frame: 12 months ]
  • Incident Kidney Stones [ Time Frame: 12 months ]
  • Incident Hypercalcemia [ Time Frame: 12 months ]
  • Death [ Time Frame: 12 months ]
  • Number of Urinary Tract Infections [ Time Frame: 12 months ]
  • Number of Other Infections [ Time Frame: 12 months ]

Enrollment: 107
Study Start Date: May 2010
Study Completion Date: July 2016
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102374


Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute on Aging (NIA)
The American Geriatrics Society
Investigators
Principal Investigator: Adit A Ginde, MD, MPH University of Colorado, Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01102374     History of Changes
Other Study ID Numbers: 09-0899
IND 106541 ( Other Identifier: FDA )
K23AG040708 ( U.S. NIH Grant/Contract )
First Submitted: April 11, 2010
First Posted: April 13, 2010
Results First Submitted: October 28, 2016
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Vitamin D Deficiency
Respiratory Infection
Nursing Home Residents
Geriatrics
Immunosenescence
Prevention

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents