Vitamin D Supplementation Prevents Elderly Pneumonia

April 7, 2009 updated by: Tohoku University

Vitamin D Supplementation Prevents Pneumonia in Institutionalized Elderly Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • 1-1,Seiryo-machi,Aoba-ku,Sendai, Japan, 980-8575
        • Institute of Development, Aging and Cancer, Tohoku University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of pneumonia
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tohoku University

Investigators

  • Study Chair: Hiroyuki Arai, MD, Department of Geriatrics and Gerontology, Tohoku University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Study Registration Dates

First Submitted

April 6, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Estimate)

April 8, 2009

Last Update Submitted That Met QC Criteria

April 7, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDAC-VD-01
  • KAKENHI 20390285

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bacterial Pneumonia

Clinical Trials on Vitamin D3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe