Use of COLD-fX to Prevent Respiratory Infections in Community Dwelling Seniors

NCT00240461 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2011-07-07

No results posted yet for this study

Summary

Seniors are a population vulnerable to respiratory infections. It is hypothesized that regular use of COLD-fX following an influenza vaccination would potentially augment immune response in the elderly. Use of COLD-fX may also provide additional protection again respiratory infection and reduce the incidence and severity of respiratory infections in otherwise healthy seniors.

Conditions

  • Respiratory Tract Infection

Interventions

DIETARY_SUPPLEMENT

COLD-fX natural health product

200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months

DIETARY_SUPPLEMENT

COLD-fX

400 mg COLD-fX natural health product 2 times daily for 6 months

OTHER

Placebo

crystalline substance 200 mg twice daily for 6 months

Sponsors & Collaborators

  • Afexa Life Sciences Inc

    collaborator INDUSTRY
  • IWK Health Centre

    collaborator OTHER
  • Sunnybrook Health Sciences Centre

    collaborator OTHER
  • Erasmus Medical Center

    collaborator OTHER
  • University of BC Gerontology & Diabetes Research

    collaborator OTHER
  • Capital Health, Canada

    lead OTHER

Principal Investigators

  • Gerry Predy, MD · Capital Health, Canada

  • Shelly McNeil MD · IWK Health Centre

  • Jan McElhaney · UBC Gerontology and Diabetes Research

  • Andrew Simor MD · Sunnybrook Health Sciences Centre

  • Albert Osterhaus Dr. · Erasmus Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-05-31
Completion
2008-12-31

Countries

  • Canada
  • Netherlands

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00240461 on ClinicalTrials.gov