Vitamin D Supplementation Prevents Elderly Pneumonia

Bacterial Pneumonia Clinical Trial

Official title:

Vitamin D Supplementation Prevents Pneumonia in Institutionalized Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877422
• Other study ID #: IDAC-VD-01
• Secondary ID: KAKENHI 20390285
• Status: Completed
• Phase: N/A
• First received: April 6, 2009
• Last updated: April 7, 2009
• Start date: August 2008

Study information

• Verified date: April 2009
• Source: Tohoku University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacterial Pneumonia
• Pneumonia
• Pneumonia, Bacterial

Intervention

Dietary Supplement:
• Vitamin D3
Group A and Group C are followed without drugs and Group B is followed with vitamin D3.

Locations

Country	Name	City	State
Japan	Institute of Development, Aging and Cancer, Tohoku University	1-1,Seiryo-machi,Aoba-ku,Sendai

Sponsors (1)

Lead Sponsor	Collaborator
Tohoku University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of pneumonia		one year	Yes
Secondary	all cause mortality		one year	Yes