NCT00240461

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 780 (actual)
• Sponsor: Capital Health, Canada · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Tract Infection

Interventions

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

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-05-01
• Completion: 2008-12-01
• First posted: 2005-10-18
• Last updated: 2011-07-07

Locations

5 sites across 2 countries: Canada, Netherlands