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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00240461
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : July 7, 2011
Afexa Life Sciences Inc
IWK Health Centre
Sunnybrook Health Sciences Centre
Erasmus Medical Center
University of BC Gerontology & Diabetes Research
Information provided by:
Capital Health, Canada

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infection Dietary Supplement: COLD-fX natural health product Dietary Supplement: COLD-fX Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : December 2008

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 Name: none available

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00240461

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Canada, Alberta
Alberta Health Services
Edmonton, Alberta, Canada, T5M 3Z7
Canada, British Columbia
UBC Gerontology and Diabetes Research
Vancouver, British Columbia, Canada
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Dr. Albert Osterhaus
Rotterdam, Netherlands
Sponsors and Collaborators
Capital Health, Canada
Afexa Life Sciences Inc
IWK Health Centre
Sunnybrook Health Sciences Centre
Erasmus Medical Center
University of BC Gerontology & Diabetes Research
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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

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Responsible Party: Dr. Gerry Predy, Capital Health Identifier: NCT00240461    
Other Study ID Numbers: CVT-E002-2005-2
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2011
Keywords provided by Capital Health, Canada:
Additional relevant MeSH terms:
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Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases