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

Study Overview
=================
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.

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

Conditions
-----------------
Respiratory Tract Infection

Intervention / Treatment
-----------------
* Dietary Supplement: COLD-fX natural health product
* Dietary Supplement: COLD-fX
* Other: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>200 mg COLD-fX Natural health products 2 times daily for six months | Dietary Supplement: COLD-fX natural health product<br>* 200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months<br>* Other names: dietary supplement;|
| Active Comparator: Arm 2<br>Arm 2 - 400 mg COLD FX Natural health product - 2 times daily for 6 months | Dietary Supplement: COLD-fX<br>* 400 mg COLD-fX natural health product 2 times daily for 6 months<br>* Other names: dietary supplements;|
| Placebo Comparator: 3<br>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<br>* crystalline substance 200 mg twice daily for 6 months<br>* Other names: none available;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory, infection, influenza