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

This study is ongoing, but not recruiting participants.
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: April 30, 2014
Last verified: April 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102374

Locations
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
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: April 30, 2014
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:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014