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

This study is currently recruiting participants.
Verified December 2013 by University of Colorado, Denver
Sponsor:
Collaborators:
The American Geriatrics Society
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01102374
First received: April 11, 2010
Last updated: December 2, 2013
Last verified: December 2013
  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
Vitamin D
Respiratory Infection
Drug: High Dose Vitamin D
Drug: Standard Dose Vitamin D
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    ARIs defined as upper or lower respiratory infections


Secondary Outcome Measures:
  • Severity of acute respiratory infections [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    ARIs resulting in emergency department visits or hospitalizations

  • Time to first ARI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in 25-hydroxyvitamin D (25OHD) level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in parathyroid hormone level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Falls [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Fractures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of upper respiratory infections [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of lower respiratory infections [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of influenza-like illnesses [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incident kidney stones [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Incident hypercalcemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of urinary tract infections [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of other infections [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose Vitamin D Drug: High Dose Vitamin D
Vitamin D3 100,000 IU monthly
Active Comparator: Standard Dose Vitamin D Drug: Standard Dose Vitamin D
Vitamin D 400-1000 IU per day

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102374

Contacts
Contact: Adit A Ginde, MD, MPH 720-848-6777 adit.ginde@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Adit A Ginde, MD, MPH    720-848-6777    adit.ginde@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
The American Geriatrics Society
Investigators
Principal Investigator: Adit A Ginde, MD, MPH University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01102374     History of Changes
Other Study ID Numbers: 09-0899, IND 106541
Study First Received: April 11, 2010
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014