Vitamin D Supplementation Prevents Elderly Pneumonia

NCT00877422 | Completed

• 2 other identifiers: IDAC-VD-01KAKENHI 20390285
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Pneumonia

Keywords

vitamin deficiency

Outcome Measures

Primary Outcomes (1)

• prevalence of pneumonia

  one year

Secondary Outcomes (1)

• all cause mortality

  one year

Study Arms (3)

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

Vitamin D3 DIETARY_SUPPLEMENT

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

Group B

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tohoku University: lead

Study Sites (1)

Institute of Development, Aging and Cancer, Tohoku University

1-1,Seiryo-machi,Aoba-ku,Sendai, 980-8575, Japan

Location

MeSH Terms

Conditions

Pneumonia, Bacterial; Avitaminosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Hiroyuki Arai, MD

  Department of Geriatrics and Gerontology, Tohoku University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2009
• First Posted: April 7, 2009
• Study Start: August 1, 2008
• Last Updated: April 8, 2009

Record last verified: 2009-04

Locations

JP (1)