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

Phase 2

Completed

• Conditions: Knee Osteoarthritis (OA)
• Interventions: Dietary Supplement: Collagen Hydrolysate; Dietary Supplement: Placebo

• Registration Number: NCT00536302
• Lead Sponsor: GELITA

Brief 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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-09-26
• Study First Submitted QC: 2007-09-26
• Study First Posted: 2007-09-27
• Primary Completion: 2008-11
• Study Completion: 2009-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-05
• Last Update Posted: 2009-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• age > 49 years
• chronic knee discomfort based on the affirmative response to the question "During the past 6 months, have you had any pain in the knee more than half the days of the month ?"
• WOMAC pain subscale score ≥ 1
• tibiofemoral or patellofemoral osteoarthritis on anteroposterior weight-bearing semi-flexed or lateral knee radiographs with at least one osteophyte and no significant joint-space-narrowing
• clinical examination confirming knee pain or discomfort referable to the knee joint
• prepared to refrain from use of glucosamine, chondroitin, sAME and doxycycline
• stable medication and/or supplement use

Exclusion Criteria

• use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization
• serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial
• individuals who are expected not to comply with the study protocol
• plan to permanently relocate from the region during the trial period
• planned knee arthroplasty in the study knee
• active pathology of confounding origin which may cause pain, extending to the knee
• pregnancy
• any contra-indication to having an MRI scan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Collagen Hydrolysate	Collagen Hydrolysate
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.	48 Weeks

Secondary Outcome Measures

Name	Time	Method
To measure knee cartilage volume over 48 weeks at three time points.	48 Weeks
To measure and evaluate WOMAC pain subscale scores over 48 weeks.	48 Weeks
To evaluate change in physical function tests over 48 weeks.	48 Weeks

Trial Locations

Locations (1)

Tufts Medical Center; Center for Arthritis and Rheumatic Diseases; 🇺🇸 Boston, Massachusetts, United States