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

July 6, 2011 updated by: Capital Health, Canada

Efficacy and Safety of COLD-fX in the Prevention of Respiratory Infections in Community-dwelling Seniors: a Multi-center, Randomized, Double-blind, Placebo-controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eligible seniors will be randomly placed into three groups to receive 400 mg/day, 800mg/day or a placebo for a period of six months beginning in October. Daily dosing will be recorded as well as any symptoms not related to having a respiratory infection. For seniors who experience a respiratory infection, they are asked to call a study nurse who will take a nasopharyngeal swab. The seniors are also asked to record on a diary card the severity of their symptoms on a scale from 0-3 (none, mild, moderate, severe). Symptoms include cough, fever, runny nose, stuff nose, aches and pains, headache, chills, sneezing, ear aches and fatigue.The swab will be taken to the lab for testing for upper respiratory viruses.

Study Type

Interventional

Enrollment (Actual)

780

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5M 3Z7
        • Alberta Health Services
    • British Columbia
      • Vancouver, British Columbia, Canada
        • UBC Gerontology and Diabetes Research
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • IWK Health Centre
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
  • Netherlands
      • Rotterdam, Netherlands
        • Dr. Albert Osterhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 65 years of age and older
  • current season influenza immunization
  • available for follow-up visits
  • willing and able to sign written informed consent

Exclusion Criteria:

  • HIV infection
  • malignancy (under active observation or treatment)
  • unstable cardiovascular diseases
  • renal abnormalities (serum creatine >200umol/l)
  • pulmonary disease (chronic bronchitis, emphysema, or asthma requiring treatment in the last 3 months with oral steroids - prednisone >10mg/day, other chronic respiratory illness)
  • acute or active chronic liver disease
  • neurologic or psychiatric disease (progressive or currently under treatment
  • active tuberculosis
  • multiple sclerosis
  • bleeding disorders
  • planned surgery over the course of the trial
  • on immunosuppressive therapy
  • taking oral steroids at dose = to prednisone 10 mg/day or more
  • taking phenelzine, pentobarbital, haloperidol, warfarin, heparin
  • use of natural health products(except the study product and vitamins and minerals with a dose <600 mg/day of vitamin E and containing no vitamin K) including echinacea or ginseng-containing products (tea, capsules, extracts, tablets)
  • current alcohol/drug abuse
  • major surgery in the past 6 months
  • allergies to ginseng

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
200 mg COLD-fX Natural health products 2 times daily for six months
Dietary supplement: COLD-fX natural health product
200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months
Other Names:
  • Natural health product
  • dietary supplement
Active Comparator: Arm 2
Arm 2 - 400 mg COLD FX Natural health product - 2 times daily for 6 months
Dietary supplement: COLD-fX
400 mg COLD-fX natural health product 2 times daily for 6 months
Other Names:
  • naural health products
  • dietary supplements
Placebo Comparator: 3
Inactive crystalline substance. This is the placebo arm in which subject receive 200 mg of the placebo 2 times daily for 6 months. Placebo is an inactive crystalline substance.
Other: Placebo
crystalline substance 200 mg twice daily for 6 months
Other Names:
  • none available

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections.
Time Frame: During the study time frame of 6 months
During the study time frame of 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the effects of the treatment on the incidence and frequency of all respiratory infections meeting the Jackson criteria and to determine the efficacy of COLD-fX supplementation on the severity and duration of symptoms.
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Health, Canada

Collaborators

Sunnybrook Health Sciences Centre
Erasmus Medical Center
IWK Health Centre
Afexa Life Sciences Inc
University of BC Gerontology & Diabetes Research

Investigators

  • Principal Investigator: Gerry Predy, MD, Capital Health, Canada
  • Principal Investigator: Shelly McNeil MD, IWK Health Centre
  • Principal Investigator: Jan McElhaney, UBC Gerontology and Diabetes Research
  • Principal Investigator: Andrew Simor MD, Sunnybrook Health Sciences Centre
  • Principal Investigator: Albert Osterhaus Dr., Erasmus Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 14, 2005

First Submitted That Met QC Criteria

October 14, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

July 7, 2011

Last Update Submitted That Met QC Criteria

July 6, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVT-E002-2005-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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