Respiratory Tract Infection
Conditions
Keywords
respiratory, infection, influenza
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.
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.
Interventions
DIETARY_SUPPLEMENTCOLD-fX natural health product
200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months
DIETARY_SUPPLEMENTCOLD-fX
400 mg COLD-fX natural health product 2 times daily for 6 months
OTHERPlacebo
crystalline substance 200 mg twice daily for 6 months
Sponsors
Afexa Life Sciences Inc
IWK Health Centre
Sunnybrook Health Sciences Centre
Erasmus Medical Center
University of BC Gerontology & Diabetes Research
Capital Health, Canada
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections. | During the study time frame of 6 months |
Secondary
| 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. | six months |
Countries
Canada, Netherlands
Outcome results
None listed