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

Respiratory Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00240461
• Other study ID #: CVT-E002-2005-2
• Status: Completed
• Phase: Phase 3
• First received: October 14, 2005
• Last updated: July 6, 2011
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: July 2011
• Source: Capital Health, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: December 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• COLD-fX natural health product
200 mg/COLD-fX natural health product - 2 capsules twice daily for 6 months
• 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

Locations

Country	Name	City	State
Canada	Alberta Health Services	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	UBC Gerontology and Diabetes Research	Vancouver	British Columbia
Netherlands	Dr. Albert Osterhaus	Rotterdam

Sponsors (6)

Lead Sponsor	Collaborator
Capital Health, Canada	Afexa Life Sciences Inc, Erasmus Medical Center, IWK Health Centre, Sunnybrook Health Sciences Centre, University of BC Gerontology & Diabetes Research

Countries where clinical trial is conducted

Canada,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes