Vitamin D Supplementation Prevents Elderly Pneumonia

Sponsor

Tohoku University (Other)

Overall Status

Completed

CT.gov ID

NCT00877422

Collaborator

(none)

100

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Pneumonia	Dietary Supplement: Vitamin D3	N/A

Study Design

Study Type:

Interventional

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 :

Aug 1, 2008

Arms and Interventions

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.

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

Primary Outcome Measures

prevalence of pneumonia [one year]

Secondary Outcome Measures

all cause mortality [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00877422

Other Study ID Numbers:

IDAC-VD-01
KAKENHI 20390285

First Posted:

Apr 7, 2009

Last Update Posted:

Apr 8, 2009

Last Verified:

Apr 1, 2009

Keywords provided by , ,

vitamin deficiency

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2009