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Completed

NCT Number: NCT00240461

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

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.

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Key information

Conditions

Respiratory Tract Infection Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alberta Health Services, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COLD-fX natural health product

Dietary Supplement

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

Other names: Natural health product, dietary supplement

COLD-fX

Dietary Supplement

400 mg COLD-fX natural health product 2 times daily for 6 months

Other names: naural health products, dietary supplements

Placebo

Other

crystalline substance 200 mg twice daily for 6 months

Other names: none available

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Capital Health, Canada

Other

Collaborators

  • Afexa Life Sciences Inc
  • Erasmus Medical Center
  • IWK Health Centre
  • Sunnybrook Health Sciences Centre
  • University of BC Gerontology & Diabetes Research

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 18, 2005
Registry last updated
Jul 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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