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

Capital Health, Canada

Status and phase: Completed; Phase 3

Conditions: Respiratory Tract Infection

Treatments: Dietary Supplement: COLD-fX; Dietary Supplement: COLD-fX natural health product; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00240461

CVT-E002-2005-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 780 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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780 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

200 mg COLD-fX Natural health products 2 times daily for six months

Treatment:

Dietary Supplement: COLD-fX natural health product

Arm 2

Active Comparator group

Description:

Arm 2 - 400 mg COLD FX Natural health product - 2 times daily for 6 months

Treatment:

Dietary Supplement: COLD-fX

3

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo