Vitamin D Supplementation Prevents Elderly Pneumonia | NCT00877422

Studies
Vitamin D Supplementation Prevents Elderly Pneumonia

NCT00877422

Sponsor

Tohoku University

Status

Completed

Last Update Posted

Apr 8, 2009Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Bacterial Pneumonia

Interventions

Vitamin D3

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KAKENHI 20390285

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Apr 6, 2009

First Submission Date that Met QC Criteria

Apr 6, 2009

First Posted Date

Apr 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2009

Last Update Posted Date

Apr 8, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	No Intervention	Group A is identified as serum vitamin D level more than 16 ng/dl.
Group B	Active Comparator	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 C	No Intervention	Group C is identified as serum vitamin D less than 16 ng/dl and is not supplemented with vitamin D3.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D3	Dietary Supplement	Group A and Group C are followed without drugs and Group B is followed with vitamin D3.	Group B

Measure	Description	Time Frame
prevalence of pneumonia		one year

Measure	Description	Time Frame
all cause mortality		one year

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroyuki Arai, MD	Department of Geriatrics and Gerontology, Tohoku University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Development, Aging and Cancer, Tohoku University		1-1,Seiryo-machi,Aoba-ku,Sendai		980-8575	Japan

Condition Browse Module

MeSH Terms

ID	Term
D018410	Pneumonia, Bacterial
D001361	Avitaminosis

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D011014	Pneumonia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided