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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bacterial Pneumonia Dietary Supplement: Vitamin D3 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Vitamin D Supplementation Prevents Pneumonia in Institutionalized Elderly Subjects
Study Start Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Vitamin D

Arms and Interventions
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Arm Intervention/treatment
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.
 Dietary Supplement: Vitamin D3
Group A and Group C are followed without drugs and Group B is followed with 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.


Outcome Measures
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Primary Outcome Measures :
  1. prevalence of pneumonia [ Time Frame: one year ]

Secondary Outcome Measures :
  1. all cause mortality [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT00877422


Locations
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Japan
Institute of Development, Aging and Cancer, Tohoku University
1-1,Seiryo-machi,Aoba-ku,Sendai, Japan, 980-8575
Sponsors and Collaborators
Tohoku University
Investigators
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Study Chair: Hiroyuki Arai, MD Department of Geriatrics and Gerontology, Tohoku University
More Information
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Responsible Party: Takashi Ohrui/MD,PhD, Institute of Development, Aging and Cancer, Tohoku University
ClinicalTrials.gov Identifier: NCT00877422    
Other Study ID Numbers: IDAC-VD-01
KAKENHI 20390285
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: April 8, 2009
Last Verified: April 2009
Keywords provided by Tohoku University:
vitamin deficiency
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Bacterial
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Bacterial Infections
Bacterial Infections and Mycoses
 Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents