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Vitamin D Supplementation Prevents Elderly Pneumonia

Primary Purpose

Bacterial Pneumonia

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Vitamin D3

About this trial

This is an interventional prevention trial for Bacterial Pneumonia focused on measuring vitamin deficiency

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Institute of Development, Aging and Cancer, Tohoku University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

No Intervention

Arm Label

Group A

Group B

Group C

Arm Description

Group A is identified as serum vitamin D level more than 16 ng/dl.

Group B is identified as serum vitamin D level less than 16 ng/dl and is supplemented with vitamin D3.

Group C is identified as serum vitamin D less than 16 ng/dl and is not supplemented with vitamin D3.

Outcomes

Primary Outcome Measures

prevalence of pneumonia

Secondary Outcome Measures

all cause mortality

Full Information

NCT ID

NCT00877422

First Posted

April 6, 2009

Last Updated

April 7, 2009

Sponsor

Tohoku University

1. Study Identification

Unique Protocol Identification Number

NCT00877422

Brief Title

Vitamin D Supplementation Prevents Elderly Pneumonia

Official Title

Vitamin D Supplementation Prevents Pneumonia in Institutionalized Elderly Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Tohoku University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bacterial Pneumonia

Keywords

vitamin deficiency

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

No Intervention

Arm Description

Group A is identified as serum vitamin D level more than 16 ng/dl.

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

Group B is identified as serum vitamin D level less than 16 ng/dl and is supplemented with vitamin D3.

Arm Title

Group C

Arm Type

No Intervention

Arm Description

Group C is identified as serum vitamin D less than 16 ng/dl and is not supplemented with vitamin D3.

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Intervention Description

Group A and Group C are followed without drugs and Group B is followed with vitamin D3.

Primary Outcome Measure Information:

Title

prevalence of pneumonia

Time Frame

one year

Secondary Outcome Measure Information:

Title

all cause mortality

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroyuki Arai, MD

Organizational Affiliation

Department of Geriatrics and Gerontology, Tohoku University

Official's Role

Study Chair

Facility Information:

Facility Name

Institute of Development, Aging and Cancer, Tohoku University

City

1-1,Seiryo-machi,Aoba-ku,Sendai

ZIP/Postal Code

980-8575

Country

Japan

12. IPD Sharing Statement

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Vitamin D Supplementation Prevents Elderly Pneumonia

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