NCT00513422

The Long-term Evaluation of Glucosamine Sulphate Study

The Effect of Glucosamine Sulphate on Structural Disease Progression in Knee Osteoarthritis and the Cost-effectiveness of Glucosamine Sulphate for Knee Arthritis.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary aim of this study is to determine if the dietary supplements, glucosamine sulphate and/or chondroitin can limit or reduce structural disease progression whilst providing symptomatic benefit in people with osteoarthritis (OA) of the knee. The specific hypotheses to be tested in the proposed double blind, placebo-controlled, randomised clinical trial are that, compared to participants allocated to placebo, participants allocated to either or both of these dietary supplements will demonstrate: * reduced medial tibio-femoral joint space narrowing at 2 years AND; * reduced knee pain over 1 year These benefits will be achieved by participants allocated to glucosamine sulphate and/or chondroitin (the study treatments) without concomitant: * increased use of analgesics * reduced health-related quality of life * reduced participation in leisure-time physical activity

Detailed description

The LEGS study is a double blind, placebo-controlled randomised clinical trial using a 2 x 2 factorial design. Participant will be randomly allocated to one of the four possible treatment combinations: * Glucosamine and Chondroitin (double active) * Placebo Glucosamine and Chondroitin * Glucosamine and Placebo Chondroitin * Placebo Glucosamine and Placebo Chondroitin (double placebo) Each allocation involves taking 4 study treatment capsules once a day for two years. A total of 600 participants with symptomatic knee OA will be recruited by general media advertising and by General Practitioners through the New South Wales Divisions of general practice.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Glucosamine sulphate and chondroitin	Glucosamine: Two 750mg capsules once daily for two years; Chondroitin: Two 400mg capsules once daily for two years.
DIETARY_SUPPLEMENT	Glucosamine sulphate	Glucosamine: Two 750mg capsules once daily for two years; Placebo Chondroitin: Two capsules once daily for two years.
DIETARY_SUPPLEMENT	Chondroitin sulphate	Chondroitin sulphate: Two 400mg capsules once daily for two years; Placebo glucosamine: Two capsules once daily for two years.
DIETARY_SUPPLEMENT	Placebo capsules for glucosamine and chondroitin	Two placebo glucosamine capsules once daily for two years; Two placebo chondroitin capsules once daily for two years.

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2007-08-08
• Last updated: 2010-06-30

Locations

1 site across 1 country: Australia