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Vitamin D Supplementation Prevents Elderly Pneumonia

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.
 
ClinicalTrials.gov Identifier: NCT00877422
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : April 8, 2009
Sponsor:
Information provided by:
Tohoku University

Tracking Information
First Submitted Date  ICMJE April 6, 2009
First Posted Date  ICMJE April 7, 2009
Last Update Posted Date April 8, 2009
Study Start Date  ICMJE August 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
prevalence of pneumonia [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2009)
all cause mortality [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Supplementation Prevents Elderly Pneumonia
Official Title  ICMJE Vitamin D Supplementation Prevents Pneumonia in Institutionalized Elderly Subjects
Brief Summary Pneumonia is the fourth leading cause of death and frequently occurs in institutionalized elderly people in Japan. Recently, several clinical and experimental studies have reported the importance of vitamin D in the regulation of immune functions and its deficiency is associated with susceptibility to some infections. In the present study, the investigators hypothesize that deficiency of serum vitamin D is associated with development of pneumonia, and supplementation of vitamin D may lower the incidence of pneumonia and prolong survival in institutionalized elderly subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Bacterial Pneumonia
Intervention  ICMJE Dietary Supplement: Vitamin D3
Group A and Group C are followed without drugs and Group B is followed with vitamin D3.
Study Arms  ICMJE
  • No Intervention: Group A
    Group A is identified as serum vitamin D level more than 16 ng/dl.
  • Active Comparator: Group B
    Group B is identified as serum vitamin D level less than 16 ng/dl and is supplemented with vitamin D3.
    Intervention: Dietary Supplement: Vitamin D3
  • No Intervention: Group C
    Group C is identified as serum vitamin D less than 16 ng/dl and is not supplemented with vitamin D3.
Publications * Not Provided

*   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 6, 2009)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects are more than 65 years old and were resident in the facility for at least 6 months.
  • Subjects have no conditions known to interfere with vitamin D metabolism.

Exclusion Criteria:

  • Subjects are excluded if they have:

    • renal failure
    • hepatic failure
    • hyper- or hypo-parathyroidism
    • HIV infection, or malignant diseases
  • Subjects are also excluded if they are taking corticosteroid, thiazide diuretics, or supplementary vitamins.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00877422
Other Study ID Numbers  ICMJE IDAC-VD-01
KAKENHI 20390285
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takashi Ohrui/MD,PhD, Institute of Development, Aging and Cancer, Tohoku University
Study Sponsor  ICMJE Tohoku University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hiroyuki Arai, MD Department of Geriatrics and Gerontology, Tohoku University
PRS Account Tohoku University
Verification Date April 2009

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