Clinical trial NCT00240461: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Tract Infection
Keywords: respiratory
infection
influenza
Lead sponsor: Capital Health, Canada
Sponsor class: OTHER
Collaborators: name: Afexa Life Sciences Inc
name: IWK Health Centre
name: Sunnybrook Health Sciences Centre
name: Erasmus Medical Center
name: University of BC Gerontology & Diabetes Research
First posted: 2005-10-18
Enrollment: 780
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections.
timeFrame: During the study time frame of 6 months
Secondary outcomes:
measure: 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.
timeFrame: six months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Health Services
state: Alberta
city: Vancouver
country: Canada
facility: UBC Gerontology and Diabetes Research
state: British Columbia
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Rotterdam
country: Netherlands
facility: Dr. Albert Osterhaus
Study officials:
affiliation: Capital Health, Canada
name: Gerry Predy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IWK Health Centre
name: Shelly McNeil MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UBC Gerontology and Diabetes Research
name: Jan McElhaney
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Andrew Simor MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Centre
name: Albert Osterhaus Dr.
role: PRINCIPAL_INVESTIGATOR
References: