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A Single Center, Prospective, Randomized, Placebo-Controlled, Double-Blind Pilot Clinical Trial to Evaluate the Sensitivity of Magnetic Resonance Imaging to Detect Change in Cartilage Structure and Composition in 30 Participants Diagnosed With Osteoarthritis of the Knee and Treated With Collagen Hydrolysate
This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects. Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the other half of the subjects will take a placebo dose, that looks like and tastes like the collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and 48.
This is a single-site, double-blind, pilot study to evaluate the sensitivity of MRI to detect cartilage structure and composition in subjects taking daily oral collagen hydrolysate (a nutritional supplement) or placebo for 48 weeks. 30 subjects will be randomized to collagen hydrolysate or placebo (1:1 ratio). The goal is to evaluate, by MRI, knee cartilage and structure in all subjects. The primary functional outcome measure will be the WOMAC questionnaire and the primary pathological outcome measure will be knee cartilage structure and composition as measurements done by MRI imaging. Subjects will have contrast dGEMRIC MRIs done at Study Weeks -1, 24 and 48.
Age
49 - 90 years
Sex
ALL
Healthy Volunteers
No
Tufts Medical Center; Center for Arthritis and Rheumatic Diseases
Boston, Massachusetts, United States
Start Date
March 1, 2007
Primary Completion Date
November 1, 2008
Completion Date
January 1, 2009
Last Updated
February 6, 2009
30
ACTUAL participants
Collagen Hydrolysate
DIETARY_SUPPLEMENT
Placebo
DIETARY_SUPPLEMENT
Lead Sponsor
GELITA
NCT07481461
NCT06735547
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06704776