Vitamin D Supplementation Prevents Elderly Pneumonia

This study has been completed.
Sponsor:
Information provided by:
Tohoku University
ClinicalTrials.gov Identifier:
NCT00877422
First received: April 6, 2009
Last updated: April 7, 2009
Last verified: April 2009
  Purpose

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 Intervention
Bacterial Pneumonia
Dietary Supplement: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Vitamin D Supplementation Prevents Pneumonia in Institutionalized Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Tohoku University:

Primary Outcome Measures:
  • prevalence of pneumonia [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • all cause mortality [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: August 2008
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00877422

Locations
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
Study Chair: Hiroyuki Arai, MD Department of Geriatrics and Gerontology, Tohoku University
  More Information

No publications provided

Responsible Party: Takashi Ohrui/MD,PhD, Institute of Development, Aging and Cancer, Tohoku University
ClinicalTrials.gov Identifier: NCT00877422     History of Changes
Other Study ID Numbers: IDAC-VD-01, KAKENHI 20390285
Study First Received: April 6, 2009
Last Updated: April 7, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Tohoku University:
vitamin deficiency

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

ClinicalTrials.gov processed this record on September 18, 2014