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

February 5, 2009 updated by: GELITA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center; Center for Arthritis and Rheumatic Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Dietary supplement: Placebo
Matching placebo solution per day by mouth for 48 weeks.
Experimental: 1
Collagen Hydrolysate
Dietary supplement: Collagen Hydrolysate
Collagen Hydrolysate solution 10 grams per day by mouth for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the effect of collagen hydrolysate on knee cartilage as measured by MRI.
Time Frame: 48 Weeks
48 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GELITA

Investigators

  • Principal Investigator: Timothy E McAlindon, MD, MPH, Tufts Medical Center; Center for Arthritis and Rheumatic Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 26, 2007

First Posted (Estimate)

September 27, 2007

Study Record Updates

Last Update Posted (Estimate)

February 6, 2009

Last Update Submitted That Met QC Criteria

February 5, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gelita TM 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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