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

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”

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.

Intervention(s) in this Clinical Trial

• Dietary Supplement: COLD-fX natural health product
  • 200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months
• Dietary Supplement: COLD-fX
  • 400 mg COLD-fX natural health product 2 times daily for 6 months
• Other: Placebo
  • crystalline substance 200 mg twice daily for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 200 mg COLD-fX Natural health products 2 times daily for six months
• Active Comparator: Arm 2
  • Arm 2 - 400 mg COLD FX Natural health product - 2 times daily for 6 months
• 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.

Primary 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
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Capital Health, Canada Other

Overall Clinical Trial Officials and Contacts

Gerry Predy, MD Principal Investigator Capital Health, Canada  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00240461

Study ID Number: CVT-E002-2005-2

ClinicalTrials.gov Identifier: NCT00240461

Health Authority: Canada: Health Canada