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Trial record 9 of 31 for:    high dose vitamin k

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

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ClinicalTrials.gov Identifier: NCT01102374
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
The American Geriatrics Society
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE April 11, 2010
First Posted Date  ICMJE April 13, 2010
Results First Submitted Date  ICMJE October 28, 2016
Results First Posted Date  ICMJE April 21, 2017
Last Update Posted Date April 21, 2017
Study Start Date  ICMJE May 2010
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
Number of Acute Respiratory Infections (ARIs) [ Time Frame: 12 months ]
ARIs defined as upper or lower respiratory infections
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
Number of acute respiratory infections (ARIs) [ Time Frame: 12 months ]
ARIs defined as upper or lower respiratory infections
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
  • 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: 12 months ]
  • Change in parathyroid hormone level [ Time Frame: 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
Official Title  ICMJE Vitamin D Supplementation and Acute Respiratory Infection in Older Long-Term Care Residents
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Respiratory Infection
Intervention  ICMJE
  • Drug: High Dose Vitamin D
    Vitamin D3 100,000 IU monthly
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: High Dose Vitamin D
    • Dietary Supplement: Usual Care
  • 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.
    Interventions:
    • Drug: Standard Dose Vitamin D
    • Drug: Placebo
    • Dietary Supplement: Usual Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2017)
107
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2010)
200
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01102374
Other Study ID Numbers  ICMJE 09-0899
IND 106541 ( Other Identifier: FDA )
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Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE
  • National Institute on Aging (NIA)
  • The American Geriatrics Society
Investigators  ICMJE
Principal Investigator: Adit A Ginde, MD, MPH University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP