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

Knee Osteoarthritis (OA) Clinical Trial

— NMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536302
• Other study ID #: Gelita TM 1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 26, 2007
• Last updated: February 5, 2009
• Start date: March 2007
• Est. completion date: January 2009

Study information

• Verified date: February 2009
• Source: GELITA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 49 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis (OA)
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Collagen Hydrolysate
Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks
• Placebo
Matching placebo solution per day by mouth for 48 weeks.

Locations

Country	Name	City	State
United States	Tufts Medical Center; Center for Arthritis and Rheumatic Diseases	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GELITA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.		48 Weeks	No
Secondary	To measure knee cartilage volume over 48 weeks at three time points.		48 Weeks	No
Secondary	To measure and evaluate WOMAC pain subscale scores over 48 weeks.		48 Weeks	No
Secondary	To evaluate change in physical function tests over 48 weeks.		48 Weeks	No