- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00536302
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
-
-
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
47 years to 88 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
|
Matching placebo solution per day by mouth for 48 weeks.
|
Experimental: 1
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
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.
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
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.
Clinical Trials on Knee Osteoarthritis (OA)
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
National Taiwan University HospitalRecruitingOsteoarthritis (OA) of the KneeTaiwan
-
Orient Europharma Co., Ltd.Completed
-
Mayo ClinicEnrolling by invitationOsteoarthritis | Knee Osteoarthritis | OAUnited States
-
LG ChemCompletedOsteoarthritis (OA) of the KneePoland
-
University of UtahActive, not recruitingPlatelet-Rich Plasma (PRP) | Knee Osteoarthritis (OA)United States
-
MoximedWithdrawnOsteoarthritis (OA) of the Medial Knee Compartment
-
Dow University of Health SciencesRecruitingKnee Osteoarthritis | Osteo Arthritis Knee | OA KneePakistan
-
Rambam Health Care CampusCompletedKnee, Osteoarthritis (OA) | Biomarkers for Prediction of OA Treatment EfficacyIsrael
-
Thammasat UniversityCompletedSeverity of OA Knee | Difference of Joint Space Width Between One-leg and Both-leg Standing RadiographThailand
Clinical Trials on Collagen Hydrolysate
-
Rousselot BVBABioTeSys GmbHActive, not recruitingHealthy | Prediabetic StateGermany
-
Maastricht University Medical CenterCompletedGlucose Metabolism | Lipid MetabolismNetherlands
-
Shan May YongChang Gung Memorial HospitalCompleted
-
Helse Møre og Romsdal HFHaukeland University HospitalCompletedHealthy VolunteersNorway
-
Natural Immune Systems IncRecruiting
-
Abbott NutritionCompleted
-
Nuritas LtdAtlantia Food Clinical TrialsCompleted
-
BioActorCompletedMuscle Strength Recovery
-
Atlantia Food Clinical TrialsTerminated
-
Abyss IngredientsDaacroCompletedSleep DisorderGermany