Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)
1 other identifier
interventional
1,588
1 country
16
Brief Summary
This study will determine whether glucosamine, chondroitin sulfate and/or the combination of glucosamine and chondroitin sulfate are more effective than placebo and whether the combination is more effective than glucosamine or chondroitin sulfate alone in the treatment of knee pain associated with osteoarthritis (OA) of the knee after six months of follow-up. These substances, marketed in the United States as dietary supplements, have been widely touted by the lay press and by anecdotal personal experience as effective in treating OA. To date, however, only a few small studies have been published in the worldwide literature. The study proposed herein has been carefully constructed to definitively determine the efficacy of these agents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2000
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2000
CompletedFirst Submitted
Initial submission to the registry
April 5, 2002
CompletedFirst Posted
Study publicly available on registry
April 8, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2004
CompletedJanuary 21, 2009
November 1, 2006
April 5, 2002
January 20, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-7201, United States
*University of Arizona Arthritis Center
Tucson, Arizona, 85724, United States
*Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
*University of California, Los Angeles
Los Angeles, California, 90095, United States
*University of California San Francisco
San Francisco, California, 94110, United States
Northwestern University
Chicago, Illinois, 60611, United States
*Indiana University School of Medicine
Indianapolis, Indiana, 46202-5103, United States
*Arthritis Research and Clinical Centers
Wichita, Kansas, 67214, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3025, United States
Hospital for Joint Diseases
New York, New York, 10003, United States
*Case Western Reserve University
Beachwood, Ohio, 44122, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
*University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Arthritis Consultation Center
Dallas, Texas, 75231-4496, United States
*University of Utah
Salt Lake City, Utah, 84132, United States
Virginia Mason Research Center
Seattle, Washington, 98101, United States
Related Publications (2)
Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, Lane NE, Cush JJ, Moreland LW, Schumacher HR Jr, Oddis CV, Wolfe F, Molitor JA, Yocum DE, Schnitzer TJ, Furst DE, Sawitzke AD, Shi H, Brandt KD, Moskowitz RW, Williams HJ. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med. 2006 Feb 23;354(8):795-808. doi: 10.1056/NEJMoa052771.
PMID: 16495392RESULTSawitzke AD, Shi H, Finco MF, Dunlop DD, Bingham CO 3rd, Harris CL, Singer NG, Bradley JD, Silver D, Jackson CG, Lane NE, Oddis CV, Wolfe F, Lisse J, Furst DE, Reda DJ, Moskowitz RW, Williams HJ, Clegg DO. The effect of glucosamine and/or chondroitin sulfate on the progression of knee osteoarthritis: a report from the glucosamine/chondroitin arthritis intervention trial. Arthritis Rheum. 2008 Oct;58(10):3183-91. doi: 10.1002/art.23973.
PMID: 18821708DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
April 5, 2002
First Posted
April 8, 2002
Study Start
April 1, 2000
Study Completion
February 1, 2004
Last Updated
January 21, 2009
Record last verified: 2006-11