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

NCT00240461 | Completed Phase 3

• 1 other identifier: CVT-E002-2005-2
• Study Type: interventional
• Target: 780
• Locations: 2 countries
• Sites: 5

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.

Conditions

Respiratory Tract Infection

Keywords

respiratory; infection; influenza

Outcome Measures

Primary Outcomes (1)

• 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

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.

  six months

Study Arms (3)

1

ACTIVE COMPARATOR

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

Dietary Supplement: COLD-fX natural health product

Arm 2

ACTIVE COMPARATOR

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

Dietary Supplement: COLD-fX

3

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

COLD-fX natural health product DIETARY_SUPPLEMENT

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

Also known as: Natural health product, dietary supplement

1

COLD-fX DIETARY_SUPPLEMENT

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

Also known as: naural health products, dietary supplements

Arm 2

Placebo OTHER

crystalline substance 200 mg twice daily for 6 months

Also known as: none available

3

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years of age and older
• current season influenza immunization
• available for follow-up visits
• willing and able to sign written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Capital Health, Canada: lead
• Afexa Life Sciences Inc: collaborator
• IWK Health Centre: collaborator
• Sunnybrook Health Sciences Centre: collaborator
• Erasmus Medical Center: collaborator
• University of BC Gerontology & Diabetes Research: collaborator

Study Sites (5)

Alberta Health Services

Edmonton, Alberta, T5M 3Z7, Canada

Location

UBC Gerontology and Diabetes Research

Vancouver, British Columbia, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Dr. Albert Osterhaus

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Infections; Influenza, Human

Interventions

Dietary Supplements; COLD-fX

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Gerry Predy, MD

  Capital Health, Canada

  PRINCIPAL INVESTIGATOR

• Shelly McNeil MD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

• Jan McElhaney

  UBC Gerontology and Diabetes Research

  PRINCIPAL INVESTIGATOR

• Andrew Simor MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Albert Osterhaus Dr.

  Erasmus Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 14, 2005
• First Posted: October 18, 2005
• Study Start: September 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 7, 2011

Record last verified: 2011-07

Locations

NL (1); CA (4)