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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00240461
First received: October 14, 2005
Last updated: July 6, 2011
Last verified: July 2011
  Purpose

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 Intervention Phase
Respiratory Tract Infection
Dietary Supplement: COLD-fX natural health product
Dietary Supplement: COLD-fX
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Capital Health, Canada:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 780
Study Start Date: September 2005
Study Completion Date: December 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240461

Locations
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
Netherlands
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
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
  More Information

No publications provided

Responsible Party: Dr. Gerry Predy, Capital Health
ClinicalTrials.gov Identifier: NCT00240461     History of Changes
Other Study ID Numbers: CVT-E002-2005-2
Study First Received: October 14, 2005
Last Updated: July 6, 2011
Health Authority: Canada: Health Canada

Keywords provided by Capital Health, Canada:
respiratory
infection
influenza

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014