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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
780
200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months
400 mg COLD-fX natural health product 2 times daily for 6 months
crystalline substance 200 mg twice daily for 6 months
Alberta Health Services
Edmonton, Alberta, Canada
UBC Gerontology and Diabetes Research
Vancouver, British Columbia, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
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
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
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Dr. Albert Osterhaus
Rotterdam, Netherlands