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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00240461
Other study ID # CVT-E002-2005-2
Secondary ID
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


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
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