NCT00536302

A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA)

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: GELITA · Industry
• Sex: All
• Age: 49 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Knee Osteoarthritis (OA)

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Collagen Hydrolysate	Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks
DIETARY_SUPPLEMENT	Placebo	Matching placebo solution per day by mouth for 48 weeks.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-11-01
• Completion: 2009-01-01
• First posted: 2007-09-27
• Last updated: 2009-02-06

Locations

1 site across 1 country: United States