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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

COLD-fX natural health product

COLD-fX

Placebo

About this trial

This is an interventional prevention trial for Respiratory Tract Infection focused on measuring respiratory, infection, influenza

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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

Sites / Locations

Alberta Health Services
UBC Gerontology and Diabetes Research
IWK Health Centre
Sunnybrook Health Sciences Centre
Dr. Albert Osterhaus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

Arm 2

3

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

To determine the effects of COLD-fX supplementation on the incidence of laboratory and clinically confirmed upper respiratory infections.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00240461

First Posted

October 14, 2005

Last Updated

July 6, 2011

Sponsor

Capital Health, Canada

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00240461

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Capital Health, Canada

Collaborators

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

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Tract Infection

Keywords

respiratory, infection, influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

780 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Description

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

Arm Title

3

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Dietary Supplement

Intervention Name(s)

COLD-fX natural health product

Other Intervention Name(s)

Natural health product, dietary supplement

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

COLD-fX

Other Intervention Name(s)

naural health products, dietary supplements

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

none available

Intervention Description

crystalline substance 200 mg twice daily for 6 months

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: