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| Name | Class |
|---|---|
| Afexa Life Sciences Inc | INDUSTRY |
| IWK Health Centre | OTHER |
| Sunnybrook Health Sciences Centre | OTHER |
| Erasmus Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 200 mg COLD-fX Natural health products 2 times daily for six months |
|
| Arm 2 | Active Comparator | Arm 2 - 400 mg COLD FX Natural health product - 2 times daily for 6 months |
|
| 3 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COLD-fX natural health product | Dietary Supplement | 200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alberta Health Services | Edmonton | Alberta | T5M 3Z7 | Canada | ||
| UBC Gerontology and Diabetes Research |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| C511203 | COLD-fX |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| OTHER |
| University of BC Gerontology & Diabetes Research | OTHER |
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| COLD-fX | Dietary Supplement | 400 mg COLD-fX natural health product 2 times daily for 6 months |
|
|
| Placebo | Other | crystalline substance 200 mg twice daily for 6 months |
|
|
| Vancouver |
| British Columbia |
| Canada |
| IWK Health Centre | Halifax | Nova Scotia | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Dr. Albert Osterhaus | Rotterdam | Netherlands |